MOTIVATE Weight Loss Study
NCT01679158 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2015-04-03
Summary
The purpose of this study is to evaluate the impact of minor variations in Incisionless Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety, and weight loss in the treatment of primary obesity. It will confirm, in an open prospective study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and it will help determine if they are maintained at least 6 months following the procedure. Durability of weight loss will be tracked through post-POSE visits up to 18 months following the procedure.
Conditions
Interventions
- DEVICE
-
Using The IOP system from USGI to place suture anchors
Sutures are placed in the distal body in one of three randomized techniques: "A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control
Sponsors & Collaborators
-
USGI Medical
lead INDUSTRY
Principal Investigators
-
Jorge C. Espinos, MD · Centro Medico Teknon
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- Spain
Study Locations
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