Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-02 @ 10:05 AM
Study NCT ID:
NCT07237750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Radial Compression Gastroplasty(ERCG) vs Optimized Lifestyle Intervention for Overweight and Mild-to-Moderate Obesity
Sponsor:
Liu Yan
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Single-blind, Randomized Controlled Trial Comparing Endoscopic Radial Compression Gastroplasty (ERCG) With Optimized Lifestyle Intervention in Asian Adults With BMI 24.0-34.9 kg/m²
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERCG-RCT
Brief Summary:
Obesity and overweight are rising in Asian populations, where metabolic risks begin at lower BMI thresholds than in Western cohorts. Many individuals with overweight or mild-to-moderate obesity are ineligible or unwilling to undergo bariatric surgery due to invasiveness and risk. Endoscopic bariatric and metabolic therapies offer minimally invasive alternatives but vary in complexity, cost, and safety profiles. Investigators developed a sutureless endoscopic procedure, Endoscopic Radial Compression Gastroplasty (ERCG), which reduces gastric volume by apposing gastric walls using a clip-and-loop system. This randomized controlled trial evaluates the efficacy and safety of ERCG versus an optimized lifestyle intervention in Asian adults with BMI 24.0-34.9 kg/m² who have not succeeded with conservative measures. Preliminary studies suggest ERCG can achieve approximately 15% total body weight loss (TBWL) at 12 months. The primary endpoint is percent TBWL at 12 months; secondary outcomes include changes in BMI, metabolic parameters, liver steatosis/fibrosis indices, quality of life, and adverse events. Results are expected to inform the role of ERCG as a safe, effective, and scalable option between conservative care and bariatric surgery.
Detailed Description:
The prevalence of obesity and overweight continues to increase worldwide, and Asian populations are particularly vulnerable due to lower thresholds for metabolic risk compared with Western populations. Individuals with overweight or mild-to-moderate obesity (BMI 24.0-34.9 kg/m²) often fail conservative measures but are ineligible or unwilling to undergo bariatric surgery because of its invasiveness, risk, and costs. This creates an unmet need for minimally invasive, effective, and scalable interventions.
Endoscopic bariatric and metabolic therapies (EBMTs) have emerged as alternatives, but many existing procedures involve technically complex endoscopic suturing, high costs, or device-related risks. Investigators developed ERCG, a novel sutureless endoscopic procedure that reduces gastric volume by apposing the gastric walls using a newly designed clip-and-loop system. Preliminary studies demonstrated that ERCG can induce rapid weight loss, with mean percent total body weight loss (TBWL) of approximately 15% at 12 months, while maintaining a favorable safety profile.
This randomized controlled trial aims to evaluate the efficacy and safety of ERCG compared with an optimized lifestyle intervention (OLI) in Asian adults with overweight and mild-to-moderate obesity who have failed conservative weight reduction efforts. Eligible participants will be randomized 1:1.5 into two groups. The experimental group will undergo ERCG under general anesthesia or deep sedation, following a standardized perioperative protocol, then receive structured OLI. The control group will receive structured OLI consisting of individualized dietary counseling, caloric restriction, exercise prescription, and behavioral support. Follow-up visits are scheduled at 3 months, 6 months, 12 months after enrollment.
The primary endpoint is percent TBWL at 12 months, assessed using standardized weight measurement protocols. Secondary endpoints include %TBWL at 6 and 12 months, changes in BMI, metabolic parameters (fasting plasma glucose, HbA1c, insulin resistance indices, lipid profile), liver steatosis and fibrosis indices (e.g., controlled attenuation parameter and liver stiffness by transient elastography), quality of life assessed by validated questionnaires (IWQOL-Lite), and the incidence of adverse events classified according to international standards.
Randomization will be computer-generated with concealed allocation, and outcome assessors will be blinded to treatment assignment. Analyses will follow the intention-to-treat principle with appropriate methods for handling missing data.
The study is expected to generate high-quality evidence regarding the short-term and medium-term efficacy of ERCG, to clarify its safety profile, and to determine whether ERCG can serve as a safe and scalable option bridging the therapeutic gap between conservative lifestyle approaches and bariatric surgery for overweight and mildly to moderately obese Asian populations.
Endoscopic bariatric and metabolic therapies (EBMTs) have emerged as alternatives, but many existing procedures involve technically complex endoscopic suturing, high costs, or device-related risks. Investigators developed ERCG, a novel sutureless endoscopic procedure that reduces gastric volume by apposing the gastric walls using a newly designed clip-and-loop system. Preliminary studies demonstrated that ERCG can induce rapid weight loss, with mean percent total body weight loss (TBWL) of approximately 15% at 12 months, while maintaining a favorable safety profile.
This randomized controlled trial aims to evaluate the efficacy and safety of ERCG compared with an optimized lifestyle intervention (OLI) in Asian adults with overweight and mild-to-moderate obesity who have failed conservative weight reduction efforts. Eligible participants will be randomized 1:1.5 into two groups. The experimental group will undergo ERCG under general anesthesia or deep sedation, following a standardized perioperative protocol, then receive structured OLI. The control group will receive structured OLI consisting of individualized dietary counseling, caloric restriction, exercise prescription, and behavioral support. Follow-up visits are scheduled at 3 months, 6 months, 12 months after enrollment.
The primary endpoint is percent TBWL at 12 months, assessed using standardized weight measurement protocols. Secondary endpoints include %TBWL at 6 and 12 months, changes in BMI, metabolic parameters (fasting plasma glucose, HbA1c, insulin resistance indices, lipid profile), liver steatosis and fibrosis indices (e.g., controlled attenuation parameter and liver stiffness by transient elastography), quality of life assessed by validated questionnaires (IWQOL-Lite), and the incidence of adverse events classified according to international standards.
Randomization will be computer-generated with concealed allocation, and outcome assessors will be blinded to treatment assignment. Analyses will follow the intention-to-treat principle with appropriate methods for handling missing data.
The study is expected to generate high-quality evidence regarding the short-term and medium-term efficacy of ERCG, to clarify its safety profile, and to determine whether ERCG can serve as a safe and scalable option bridging the therapeutic gap between conservative lifestyle approaches and bariatric surgery for overweight and mildly to moderately obese Asian populations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: