Endoscopic Suturing for Primary Obesity Treatment
Condition: Obesity; Body Weight; Overweight
MeSH terms: Obesity; Overweight; Body Weight
Study type: Interventional

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.
    

Intervention name(s): Endoscopic gastric restrictive procedure
Intervention type(s): Device
Intervention description(s): Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Other intervention name(s): Apollo Overstitch Endoscopic Suturing System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; BMI; Weight loss; Gastric restriction; Bariatrics