Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity
NCT02191501 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2019-02-22
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
Interventions
- PROCEDURE
-
Pyloric restriction
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.
Sponsors & Collaborators
-
American Society for Gastrointestinal Endoscopy
collaborator OTHER -
Northwell Health
lead OTHER
Principal Investigators
-
Larry S Miller, MD · Northwell Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-07
- Primary Completion
- 2017-08-01
- Completion
- 2017-11-09
Countries
- United States
Study Locations
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