Obesity Clinical Trial
— GETLEANOfficial title:
Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GET LEAN)
NCT number | NCT02248688 |
Other study ID # | Q131650 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | November 2019 |
Verified date | December 2021 |
Source | Dayton Interventional Radiology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is not designed to achieve new indications for this device.
Status | Completed |
Enrollment | 5 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 65 Years |
Eligibility | Inclusion Criteria: Morbid obesity with a BMI = 40 Age = 22years Ability to lay supine on an angiographic table <400lbs due to table weight limits Appropriate anesthesia risk as determined by certified anesthesia provider evaluation preprocedure. Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and also participate in the informed consent). Subjects who have failed previous attempts at weight loss through diet, exercise, and behavior modification (as it is recommended that conservative options, such as supervised low calorie diets combined with behavior therapy and exercise, should be attempted prior to enrolling in this study). Exclusion Criteria: Less than 22 years of age Major surgery within the past eight weeks Previous gastric, pancreatic, hepatic and splenic surgery Previous radiation therapy to the left or right upper quadrant Previous gastric, hepatic, or splenic embolization Any history of portal venous hypertension Serum creatinine > 1.8 mg/dL History of kidney problems Pregnant or intend to become pregnant within one year History of severe bleeding disorder (platelet count less than 40,000) Allergy to materials in the embolic agents (acrylamido polyvinyl alcohol macromer) Enrolled in another study Any patient who has a history of allergic reaction to iodinated contrast Abnormal baseline gastric emptying study Patients taking anti-coagulants or antiplatelet drugs Patients currently taking or requiring chronic use of NSAID or steroid medications Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting Patients with any history of peptic ulcer disease Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities. Patients with any contraindications for monitored anesthesia care or general surgery Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism Patients with active substance abuse or alcoholism Patients with defined noncompliance with previous medical care Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy. Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns. Patients with hiatal hernia Patients with known aortic disease, such as dissection or aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy |
Country | Name | City | State |
---|---|---|---|
United States | Dayton Interventional Radiology | Dayton | Ohio |
Lead Sponsor | Collaborator |
---|---|
Dayton Interventional Radiology | Ohio State University |
United States,
Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232. Erratum in: Radiology. 2008 Dec;249(3):1083. Patel, Tarek T [corrected to Patel, Tarak H]. — View Citation
Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25. — View Citation
Bookstein JJ, Chlosta EM, Foley D, Walter JF. Transcatheter hemostasis of gastrointestinal bleeding using modified autogenous clot. Radiology. 1974 Nov;113(2):277-85. — View Citation
Bradley EL 3rd, Goldman ML. Gastric infarction after therapeutic embolization. Surgery. 1976 Apr;79(4):421-4. — View Citation
Brown KT, Friedman WN, Marks RA, Saddekni S. Gastric and hepatic infarction following embolization of the left gastric artery: case report. Radiology. 1989 Sep;172(3):731-2. — View Citation
Castañeda-Zuñiga WR, Jauregui H, Rysavy J, Amplatz K. Selective transcatheter embolization of the upper gastrointestinal tract: an experimental study. Radiology. 1978 Apr;127(1):81-3. — View Citation
Miller DL, Balter S, Cole PE, Lu HT, Schueler BA, Geisinger M, Berenstein A, Albert R, Georgia JD, Noonan PT, Cardella JF, St George J, Russell EJ, Malisch TW, Vogelzang RL, Miller GL 3rd, Anderson J; RAD-IR study. Radiation doses in interventional radiology procedures: the RAD-IR study: part I: overall measures of dose. J Vasc Interv Radiol. 2003 Jun;14(6):711-27. — View Citation
Morris DC, Nichols DM, Connell DG, Burhenne HJ. Embolization of the left gastric artery in the absence of angiographic extravasation. Cardiovasc Intervent Radiol. 1986;9(4):195-8. — View Citation
Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21. — View Citation
Paxton BE, Kim CY, Alley CL, Crow JH, Balmadrid B, Keith CG, Kankotia RJ, Stinnett S, Arepally A. Bariatric embolization for suppression of the hunger hormone ghrelin in a porcine model. Radiology. 2013 Feb;266(2):471-9. doi: 10.1148/radiol.12120242. Epub 2012 Nov 30. — View Citation
Prochaska JM, Flye MW, Johnsrude IS. Left gastric artery embolization for control of gastric bleeding: a complication. Radiology. 1973 Jun;107(3):521-2. — View Citation
Robbins SM, Tuten TU, Clements JL, Fekete P. Angiographic diagnosis of gastric volvulus with report of a complication following left gastric artery embolization. Gastrointest Radiol. 1988;13(2):112-4. — View Citation
Rösch J, Dotter CT, Brown MJ. Selective arterial embolization. A new method for control of acute gastrointestinal bleeding. Radiology. 1972 Feb;102(2):303-6. — View Citation
Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Weight Average 6 Months Post-Procedure | The mean body weight of all 5 participants at 6-Months post-procedure. | 6-Month | |
Primary | Body Weight Average 12 Months Post-Procedure | The mean body weight of all 5 participants at 12-Months post-procedure. | 12-Month | |
Primary | Change in Average Body Weight From Baseline at 6 Months Post-Procedure | Average change in body weight lost.
Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.) |
Baseline, 6 Months | |
Primary | Change in Average Body Weight From Baseline at 12 Months Post-Procedure | Average change in body weight lost.
Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.) |
Baseline, 12 Months | |
Primary | Percentage of Excess Body Weight Loss at 6 Months Post-Procedure | Calculated as the average of participants:
(((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.))) |
Baseline, 6 Month | |
Primary | Percentage of Excess Body Weight Loss at 12 Months Post-Procedure | Calculated as the average of participants:
(((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.))) |
Baseline, 12 Month | |
Primary | Average Ghrelin Hormone Levels at 6 Months Post-Procedure | The mean of participant's 6-Month post-procedure Ghrelin levels. | 6-Month | |
Primary | Average Ghrelin Hormone Levels at 12 Months Post-Procedure | The mean of participant's 12-Month post-procedure Ghrelin levels. | 12-Month | |
Primary | Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure | Calculated as the average of participants:
(((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100 |
6-Month, Baseline | |
Primary | Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure | Calculated as the average of participants:
(((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100 |
12-Month, Baseline | |
Secondary | Average Leptin Hormone Levels at 6 Months Post-Procedure | The mean of participant's 6-month post-procedure Leptin levels. | 6-Month | |
Secondary | Average Leptin Hormone Levels at 12 Months Post-Procedure | The mean of participant's 12-month post-procedure Leptin levels. | 12-Month | |
Secondary | Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure | Calculated as the average of participants:
(((6-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100 |
6-Month, Baseline | |
Secondary | Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure | Calculated as the average of participants:
(((12-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100 |
12-Month, Baseline | |
Secondary | Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure | The mean of participant's 6-month post-procedure CCK levels. | 6-Month | |
Secondary | Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure | The mean of participant's 12-month post-procedure CCK levels. | 12-Month | |
Secondary | Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure | Calculated as the average of participants:
(((6-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100 |
6-Month, Baseline | |
Secondary | Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure | Calculated as the average of participants:
(((12-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100 |
12-Month, Baseline | |
Secondary | Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure | The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. | 6 Month | |
Secondary | Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure | The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.
Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS) |
6 Month, Baseline | |
Secondary | QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure | The mean of participant's 12-month post-procedure Short Form-36 Version 2 Physical Component Scores, ranging from 0-100; higher scores indicate better health status. | 12 Month | |
Secondary | Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure | The mean of participant's SF-36 Version 2 PCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.
Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS) |
12 Month, Baseline | |
Secondary | QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure | The mean of participant's SF-36 Version 2 MCS at 6-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. | 6 Month | |
Secondary | Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure | The mean of participant's SF-36 Version 2 MCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS) |
6 Month, Baseline | |
Secondary | QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure | The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. | 12 Month | |
Secondary | Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure | The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS) |
12 Month, Baseline | |
Secondary | 6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels | HgA1c Levels of diabetic patient 6-Months post-procedure. | 6-Month | |
Secondary | 12-Month Post-Procedure HgA1c Levels | HgA1c Levels of diabetic patient 12-Months post-procedure. | 12-Month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |