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

NCT02191501 | Terminated DMC

• 1 other identifier: Feinstein IRB#13-037B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Over Weight

Keywords

Obesity Treatment; Endoscopy; Pyloric Suturing; Pyloric restriction

Outcome Measures

Primary Outcomes (1)

• Percent weight loss

  The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: \[(Baseline Weight - Final 6 month Weight)/Baseline Weight\] x 100%.

  At 1, 3 and 6 months

Secondary Outcomes (5)

• Participant satisfaction

  At 6 months post procedure

• Delay in gastric emptying

  From baseline to 4 weeks post procedure

• Change in BMI

  At 1, 3 and 6 Months

• Percentage of Responders

  At 1, 3 and 6 Months

• Change in Medication Use.

  At 1, 3 and 6 Months

Study Arms (1)

Pyloric restriction

EXPERIMENTAL

Endoscopic method of pyloric restriction in order to decrease gastric emptying. The hypothesis is that this will cause and early and prolonged satiety which will inturn lead to decreased food consumption and lead to weight loss.

Procedure: Pyloric restriction

Interventions

Pyloric restriction PROCEDURE

The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract. However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested.

Pyloric restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Northwell Health: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Links

• Description and location of study

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larry S Miller, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 16, 2014
• Study Start: May 7, 2013
• Primary Completion: August 1, 2017
• Study Completion: November 9, 2017
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)