Status:
UNKNOWN
Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone
Lead Sponsor:
USGI Medical
Conditions:
Obesity
Eligibility:
All Genders
20-60 years
Phase:
NA
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 interventio...
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 los...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01843231
Start Date
September 1 2013
End Date
August 1 2016
Last Update
April 3 2015
Active Locations (3)
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1
Krakenhaus Hallein
Hallein, Salzburg, Austria
2
Atrium Medical Centre
Heerlen, Netherlands
3
Centro Medico Teknon
Barcelona, Spain