Status:
TERMINATED
Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
Conditions:
Obesity
Over Weight
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of the gastric pylorus to delay gastric emptying and treat obesity.
Detailed Description
The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis and rationale f...
Eligibility Criteria
Inclusion
- Age 18- 65
- Male or female participants with a BMI \>30 and \< 45
- Female participants of childbearing age should not be pregnant, must have a negative serum or urine test and agree to use birth control for duration of the study.
- Participant did not undergo previous Roux-en-Y bypass with the gastric pouch limited to the cardia
Exclusion
- Allergic to eggs or egg products, wheat, Gluten or Prolamins.
- currently on life saving oral medications
- Participants allergic to Scopolamine
- Participants allergic to botulinum toxin
- Participants who are currently on oral medications for their serious medical conditions.
- Recent tobacco cessation (within 3 months prior to planned enrollment) or plan to quit smoking during the study
- Infection anywhere in the body at time of procedure or other diseases that would make participant unsuitable for treatment (e.g., systemic disease, HIV, malignancy, autoimmune disease, etc.)
- patients who cannot undergo endoscopy
- Active disease of the gastrointestinal tract including esophageal inflammation, varices or ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis
- Esophageal or cricopharyngeal narrowing or stricture; distorted esophagus or known esophageal pouch
- Heavily scarred, malignant, or poor quality (e.g., friable or overly compliant) tissue in area to be sutured
- Severe eating disorders such as bulimia (use of purgatives/laxatives) or anorexia nervosa
- Significant movement limitations of lower extremities (e.g., cannot walk without the use of, or assistance from, a brace, cane, crutch, another person, prosthetic device, wheelchair, or other assistive device or is severely limited in their ability to walk due to an arthritic, neurological, or orthopedic condition)
- Recently (within previous 3 months) prescribed or initiated therapy with medication(s) known to cause significant weight gain or likely to require treatment with such medication(s) during the study OR is currently taking or has taken within the previous 3 months prescription or over-the-counter weight loss medications (e.g., medications and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.). Additionally, use of such medications and weight loss/appetite suppressing dietary supplements are prohibited during the course of the trial including the screening period
- Participant has history of significant cardiovascular or pulmonary disease (e.g., myocardial infarct, unstable angina, congestive heart failure, pulmonary edema or COPD) or other significant cerebrovascular disease (e.g., stroke)
- Not a candidate for general or conscious/moderate sedation
- Participant is on anticoagulant therapy (heparin, coumadin, Plavix, Ticlid, etc.) and must discontinue use of 325 mg aspirin within 6 weeks of procedure
- Active substance abuse (e.g., alcohol or drugs). This is done with personal interview only. No drug tests are being performed to determine the active abuse
- The participant has life expectancy of less than 1 year due to other medical conditions
- The participant is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trials study endpoints
- Patients having Diabetes
Key Trial Info
Start Date :
May 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02191501
Start Date
May 7 2013
End Date
November 9 2017
Last Update
February 22 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
North Shore University Hospital
Manhasset, New York, United States, 11030