At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial
In Brief
A clinical study evaluating Endoscopic gastric restrictive procedure for Obesity and 2 related conditions. Completed, enrolled 20 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures