Obesity and overweight are rising in Chinese populations, where metabolic risks begin atlower BMI thresholds than in Western cohorts. Many individuals with overweight ormild-to-moderate obesity are ineligible or unwilling to undergo bariatric surgery due toinvasiveness and risk. Endoscopic bariatric and metabolic therapies offer minimallyinvasive alternatives but vary in complexity, cost, and safety profiles. Investigatorsdeveloped a sutureless endoscopic procedure, Endoscopic Radial Compression Gastroplasty(ERCG), which reduces gastric volume by apposing gastric walls using a clip-and-loopsystem. This randomized controlled trial evaluates the efficacy and safety of ERCG versusan optimized lifestyle intervention in Asian adults with BMI 24.0-37.4 kg/m² who have notsucceeded with conservative measures. Preliminary studies suggest ERCG can achieveapproximately 12% total body weight loss (TBWL) at 3 months. The primary endpoint ispercent TBWL at 3 months; secondary outcomes include changes in BMI, metabolicparameters, quality of life, and adverse events. Results are expected to inform the roleof ERCG as a safe, effective, and scalable option between conservative care and bariatricsurgery.
The prevalence of obesity and overweight continues to increase worldwide, and Chinese
populations are particularly vulnerable due to lower thresholds for metabolic risk
compared with Western populations. Individuals with overweight or mild-to-moderate
obesity (BMI 24.0-37.4 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 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 12% at 3 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 Chinese adults with overweight
and mild-to-moderate obesity who have failed conservative weight reduction efforts.
Eligible participants will be randomized 1:1 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 1 month,
2 month, 3 month and 6 month after enrollment.
The primary endpoint is percent TBWL at 3 months, assessed using standardized weight
measurement protocols. Secondary endpoints include %EBWL at 3 and 6 months, changes in
BMI, metabolic parameters (fasting plasma glucose, HbA1c, insulin resistance indices,
lipid profile), 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 Chinese populations.
Procedure: Endoscopic Radial Compression Gastroplasty
Sutureless endoscopic gastric volume reduction using a novel clip-and-endoloop apposition
system; performed under general anesthesia or deep sedation; standard perioperative care.
Behavioral: Optimized Lifestyle Intervention (OLI)
Structured nutrition counseling, calorie deficit plan, physical activity prescription per
regional guidelines, and behavioral support; visit frequency matched to the ERCG arm.
Inclusion Criteria:
- Asian adults aged 18-65 years.
- BMI 24.0-37.4kg/m²(Chinese standard)。
- Failed prior conservative weight loss attempts ≥2 months。
- Willingness to comply with follow-up.
- Provided written informed consent.
Exclusion Criteria:
- Prior gastrointestinal surgery with clinically relevant sequelae.
- Active or clinically significant gastrointestinal disease, including inflammatory
conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer
disease (gastric/duodenal ulcer), or neoplastic lesions.
- Any condition associated with an increased risk of upper gastrointestinal bleeding.
- Hiatal hernia >2 cm or severe/refractory gastroesophageal reflux disease (GERD);
acid reflux requiring ≥2 medications for symptom control.
- Esophageal/pharyngeal structural abnormalities that may impede endoscope passage
(e.g., stricture, diverticulum).
- Achalasia or other severe esophageal motility disorder.
- Severe coagulopathy.
- Insulin-dependent diabetes mellitus.
- Chronic abdominal pain.
- Gastrointestinal motility disorder (e.g., gastroparesis).
- Hepatic impairment or cirrhosis.
- Severe or uncontrolled psychiatric illness.
- Alcohol abuse or substance dependence.
- Unwilling to participate in a physician-supervised diet/behavior modification
program and/or unwilling to comply with routine follow-up.
- Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating
medications.
- Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during
the treatment period.
- Known or suspected hypersensitivity to any material/component of the study system.
- Pregnant or breastfeeding.
- Severe cardiopulmonary disease or other serious systemic/organic disease.
- Positive Helicobacter pylori (H. pylori) test.
- Use of time-critical medications potentially affected by altered gastric emptying
(e.g., antiepileptics, antiarrhythmics).
- Current systemic corticosteroids, immunosuppressants, or opioid analgesics.
- Use of any weight-loss medication within the past 3 months or current use.
- Prior use of any intragastric device.
- Participation in a weight-affecting clinical trial within the past 6 months.
- Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable
coronary artery disease.
- Clinically significant respiratory disease.
- Autoimmune connective tissue disease.
- Life expectancy <1 year or severe renal/hepatic/pulmonary or other serious medical
illness.
- Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi
syndrome) or other endocrine disease known to affect body weight.
- Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating
disorder, compulsive eating).
The fifth Medical Center of Chinese PLA General Hospital, Beijing
Beijing 1816670, Beijing Municipality 2038349, China
The fifth Medical Center of Chinese PLA General Hospital, Beijing
Beijing 1816670, Beijing Municipality 2038349, China
Yan Liu, M.D. PH.D.
+8601066947300
13911798288@163.com
Yiyu Qiao, M.D. PH.D.
+8601066947300
qyy96@126.com
Not Provided