MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose ^SM vs. Medical...

Area of Science:

• Bariatric Endoscopy
• Obesity Management
• Gastrointestinal Surgery

Background:

• Pose(SM) is an endoscopic weight-loss intervention using gastric fundus and distal body suture anchors.
• Previous observational studies indicate Pose(SM) is safe and effective for weight loss.
• This study reports 12-month outcomes from a randomized controlled trial comparing Pose(SM) to conventional medical therapy.

Purpose of the Study:

• To compare the efficacy of Pose(SM) versus diet/exercise alone for weight loss in obese subjects.
• To assess changes in satiety parameters following Pose(SM) intervention.
• To evaluate the safety of the Pose(SM) procedure.

Main Methods:

• Randomized controlled trial with a 3:1 allocation to Pose(SM) or control (diet/exercise).
• Subjects with Class I-II obesity were included.
• Total body weight loss (%TBWL) and excess weight loss (%EWL) were measured at 6 and 12 months; satiety was also assessed.

Main Results:

• Pose(SM) group achieved 13.0% TBWL (45.0% EWL) versus 5.3% TBWL (18.1% EWL) in controls at 12 months (p < 0.01).
• Pose(SM) significantly improved satiety parameters (p < 0.001) at 6 and 12 months.
• No serious adverse events related to the device or procedure were reported.

Conclusions:

• Pose(SM) treatment led to significantly greater weight loss than diet/exercise alone at 12 months.
• The endoscopic intervention also demonstrated significant improvements in satiety.
• Pose(SM) represents a safe and effective endoscopic bariatric therapy.