What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Endoscopic Radial Compression Gastroplasty, Optimized Lifestyle Intervention (OLI), or Sham Endoscopic Procedure. The registry lists allocation as randomized. This randomly assigned, sham-controlled trial evaluates the how well it works and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity.
They plan to enroll about 216 people at Beijing. Taking part typically means following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.
Official title (unrewritten)
iWAIST Trial: A Multicenter, Single-Blind, Randomized, Sham-Controlled Trial of Endoscopic Radial Compression Gastroplasty (ERCG) Plus Optimized Lifestyle Intervention for Weight Management in Chinese Adults With Overweight or Mild-to-Moderate Obesity
Interventions: Endoscopic Radial Compression Gastroplasty, Optimized Lifestyle Intervention (OLI), Sham Endoscopic Procedure
Primary outcome (registry wording): Percent Total Body Weight Loss (%TBWL)