The USGI Medical ESSENTIAL Study for Weight Loss

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: placement of g-Cath EZ suture anchors; Procedure: Sham procedure; Behavioral: Diet and Exercise

• Registration Number: NCT01958385
• Lead Sponsor: USGI Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Study Start: 2013-12-01
• Primary Completion: 2015-05-01
• Study Completion: 2016-08-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Group	Diet and Exercise	The treatment of obese patients with the sham procedure along with Diet and Exercise
Treatment group	placement of g-Cath EZ suture anchors	The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise
Sham Group	Sham procedure	The treatment of obese patients with the sham procedure along with Diet and Exercise
Treatment group	Diet and Exercise	The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise

Primary Outcome Measures

Name	Time	Method
Total Body Weight Loss	Enrollment to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life scores (IWQOL)	enrollment to 12 months	Assessment of changes
Comorbid status	Enrollment to 12 months	Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia
Eating Behavior changes	Enrollment to 12 months	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

Trial Locations

Locations (11)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Hamilton Medical Center; 🇺🇸 Dalton, Georgia, United States

Crescent City Surgical Centre; 🇺🇸 Covington, Louisiana, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

Baptist Memorial; 🇺🇸 Memphis, Tennessee, United States

Lexington Medical Center; 🇺🇸 West Columbia, South Carolina, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, 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

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Saint Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States