NCT01843231

Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone

A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: USGI Medical · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss \[TBWL\] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.

Detailed description

This study will evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	g-CathTM EZ Suture Anchor Delivery Catheter	Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group
OTHER	Diet and Exercise Control Group	Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2013-04-30
• Last updated: 2015-04-03

Locations

3 sites across 3 countries: Austria, Netherlands, Spain