Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone

NCT ID: NCT01843231

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-08-31

Brief Summary

This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.

Detailed Description

This study will evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

g-Cath EZ Treatment Group

Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention

Group Type: EXPERIMENTAL

g-CathTM EZ Suture Anchor Delivery Catheter

Intervention Type: DEVICE

Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group

Diet and exercise Control Group

Diet and Exercise only control group

Group Type: ACTIVE_COMPARATOR

Diet and Exercise Control Group

Intervention Type: OTHER

Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group

Interventions

g-CathTM EZ Suture Anchor Delivery Catheter

Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group

Intervention Type: DEVICE

Diet and Exercise Control Group

Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 20-60 years
• Body Mass Index [BMI] of >30 and <40 with or without a co-morbid condition
• Subject has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
• No significant weight change (+/- 5% of total body weight) in last 6 months
• American Society Anesthesiologists-Physical Status score ≤ 2 (Appendix III),
• Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
• Has not taken any prescription or over the counter weight loss medications for at least 6 months,
• Signed informed consent.
• Subject is willing to cooperate with post-operative dietary recommendations and assessment tests,

Exclusion Criteria

• History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
• Severe gastroesophageal 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
• Known hiatal hernia >3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
• Pancreatic insufficiency/disease
• Active peptic ulcer
• Pregnancy or plans of pregnancy in the next 12 months
• Present Corticosteroid Use
• History of inflammatory disease of Gastrointestinal [GI] tract; Coagulation disorders; hepatic insufficiency or cirrhosis
• History or present use of insulin or insulin derivatives for treatment of diabetes
• Type II Diabetes Mellitus [DM] (as defined by Glycosylated Hemoglobin [HgbA1c] >6.5) for greater than 2 years at the time of enrollment
• Uncontrolled Type II DM (HgbA1c > 7.0 at screening)
• Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
• Immunosuppression
• Portal hypertension and/or varices
• Active gastric ulcer disease
• Gastric outlet obstruction or stenosis
• Beck Depression Inventory (Short) Score ≥12 (see Appendix IV);
• Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST [drug use] questionnaires or positive Urinalysis [UA] drug screen
• Severe disturbances in eating behavior (i.e. binge eating)
• Known presence of a significant depression, psychosis, or other mood or eating disorder
• Actively treated depression (except for stable treated depression for >1year and normal [Beck Depression Inventory [BDI] and psych exam)
• Present or past history of psychosis or other mood or eating disorder
• Non-ambulatory or has significant impairment of mobility
• Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
• Participating in another clinical study
• Is a first degree relative of investigator, or support staff involved in the study.
• Employed by investigator or institution involved in the study
• Subject is not able to provide written informed consent

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

USGI Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge C. Espinos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Teknon

Locations

Krakenhaus Hallein

Hallein, Salzburg, Austria

Atrium Medical Centre

Heerlen, , Netherlands

Centro Medico Teknon

Barcelona, , Spain

Countries

Austria; Netherlands; Spain

References

Miller K, Turro R, Greve JW, Bakker CM, Buchwald JN, Espinos JC. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. Obes Surg. 2017 Feb;27(2):310-322. doi: 10.1007/s11695-016-2295-9.

Reference Type: DERIVED

PMID: 27468907 (View on PubMed)

Other Identifiers

41936

Identifier Type: -

Identifier Source: org_study_id