The USGI Medical ESSENTIAL Study for Weight Loss

Obesity Clinical Trial

Official title:

A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958385
• Other study ID #: G130163
• Status: Completed
• Phase: N/A
• First received: October 4, 2013
• Last updated: March 31, 2017
• Start date: December 1, 2013
• Est. completion date: August 1, 2016

Study information

• Verified date: March 2017
• Source: USGI Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: August 1, 2016
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Provide written informed consent.

2. Be male or female subjects between the ages of 22-60 years.

3. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.

4. Have a Body Mass Index (BMI) of =30 and <35 with at least one non-severe co-morbid obesity related condition or a BMI = 35 and < 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.

5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.

6. Have an American Society Anesthesiologists-PS score = 2 (Appendix III).

7. Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.

8. Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.

9. Be willing to cooperate with post-operative dietary recommendations and assessment tests.

10. Reside within a reasonable distance from the Investigator's treating office (~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria:

1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.

2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.

3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy.

4. Large hiatal hernia (>3 cm) by history or as determined by pre-randomization endoscopy.

5. Pancreatic insufficiency/disease.

6. Active gastric erosions or gastric/duodenal ulcer.

7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.

8. Pregnancy or plans of pregnancy in the next 12 months.

9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.

10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis

11. History or present use of insulin or insulin derivatives for treatment of diabetes

12. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 10 years at the time of enrollment

13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment

14. Portal hypertension and/or varices.

15. Gastric outlet obstruction or stenosis.

16. Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.

17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.

18. Beck Depression Inventory (Short) Score =12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.

19. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.

20. Non-ambulatory or has significant impairment of mobility.

21. Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.

22. Participating in another clinical study.

23. Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.

24. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Device:
• placement of g-Cath EZ suture anchors

Procedure:
• Sham procedure

Behavioral:
• Diet and Exercise
A structured diet and exercise plan

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Crescent City Surgical Centre	Covington	Louisiana
United States	Hamilton Medical Center	Dalton	Georgia
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Baptist Memorial	Memphis	Tennessee
United States	DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine	Miami	Florida
United States	University of MN, Fairview Health Services	Minneapolis	Minnesota
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Lexington Medical Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
USGI Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sullivan S, Swain JM, Woodman G, Antonetti M, De La Cruz-Muñoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin TE, Thompson CC. Randomized s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Body Weight Loss	Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.	Enrollment to 12 months
Secondary	Quality of Life scores (IWQOL)	Assessment of changes	enrollment to 12 months
Secondary	Comorbid status	Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia	Enrollment to 12 months
Secondary	Eating Behavior changes	assessment of changes from baseline at 12 months in eating behavior scores (TFEQ) and subjective changes in food capacity, hunger, and satiety in both study groups	Enrollment to 12 months