NCT01662024

Endoscopic Suturing for Primary Obesity Treatment

Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Detailed description

The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures. The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure. Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months. Secondary Endpoints: 1. Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: * Percent excess weight loss (%EWL) * Total weight lost (kg) and percent weight lost * Change in (BMI) and percent change in BMI * Change in waist circumference * Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values * Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline) * Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline) 2. Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.

Conditions

• Obesity
• Body Weight
• Overweight

Interventions

Type	Name	Description
DEVICE	Endoscopic gastric restrictive procedure	Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-05-01
• Completion: 2016-04-01
• First posted: 2012-08-10
• Last updated: 2017-03-30
• Results posted: 2017-03-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study