Gastric Arterial Embolization for Weight Loss

Obesity Clinical Trial

Official title:

Gastric Arterial Embolization for Weight Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02872740
• Other study ID #: 15-9576
• Status: Not yet recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 18, 2016
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Title: Embolization of Gastric Arterial Supply for Weight Loss

Sample size:

10 patients

Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery.

Study Design:

Single center, randomized, prospective, non-blinded pilot study.

Study Duration:

12 months (November 2015 - December 2015).

Agent:

150-250 micron polyvinyl alcohol particles

Primary objective:

To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients.

Primary objective measure:

The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease

Exclusion Criteria:

Basic

Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment

Gastrointestinal

Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L

Cardiovascular

Known aortic pathology such as aneurysm or dissection Peripheral arterial disease

Renal

Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2

Hematologic/Immunologic/Oncologic/Infectious

Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7

Psychiatric

Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• Embolization of Left Gastric Artery
Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
• Embolization of Gastroepiploic Artery
Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Adverse events	1 year	Yes
Secondary	Weight	weight change	1 year	No
Secondary	Cardiovascular risk factors	serum lipids, hemoglobin A1C, blood pressure, sleep apnea	1 year	No