Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity

Stopped early · Not applicable

Conditions studied: Obesity, Over Weight

In brief

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.

Key facts

Study ID

NCT02191501

Run by

Northwell Health

People needed

8

Starts

2013-05-07

Expected to finish

2017-11-09

Last updated by the study team

2019-02-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• North Shore University Hospital — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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