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Overweight and/or ObesityiWAIST-RCTNCT07237750

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss

A study testing Endoscopic Radial Compression Gastroplasty and Optimized Lifestyle Intervention (OLI) in people with Overweight and/or Obesity and Metabolic Syndrome, run by Liu Yan at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized, sham-controlled trial evaluates the efficacy 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Endoscopic Radial Compression Gastroplasty and Optimized Lifestyle Intervention (OLI)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
2 sitesChina
Study dates
13 Mar 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asian adults aged 18-65 years.
  • BMI 24.0-27.9 with ≥ 1 obesity-related complication
  • BMI 28.0-37.4kg/m²
  • Failed prior conservative weight loss attempts
  • Willingness to comply with follow-up.
  • Provided written informed consent.

Who cannot join

  • 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.
Show all 31Show fewer
  • 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.
  • Active infection not successfully eradicated before enrolment.
  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Liu, M.D. PH.D. contact

+8601066947300

13911798288@163.com

Yiyu Qiao, M.D. PH.D. contact

+8601066947300

qyy96@126.com

China2 sites, 2 recruiting
  • The fifth Medical Center of Chinese PLA General Hospital, Beijing

    Beijing, Beijing Municipality, 100073

    Yan Liu, M.D. PH.D., +8601066947300, 13911798288@163.com

    Yan Liu

    Not yet recruiting
  • The fifth Medical Center of Chinese PLA General Hospital, Beijing

    Beijing, Beijing Municipality, 100073

    Recruiting

Other trials in China

About this study

Official title: 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

This randomized, sham-controlled trial evaluates the efficacy 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. The co-primary outcomes are percentage total weight loss (%TWL) at 12 weeks and the clinical response rate at 12 weeks, defined as the proportion of participants achieving %TWL ≥5%. Secondary outcomes include weight-related, metabolic, hepatic steatosis-related, imaging, symptom, quality-of-life, and safety outcomes.

Read the detailed description

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 in a 1:1 ratio to ERCG plus optimized lifestyle intervention or sham procedure plus optimized lifestyle intervention. Participants in both groups will undergo the assigned procedure under the same anesthesia strategy and procedural setting. The sham procedure will simulate the duration and peri-procedural experience of ERCG without clip or endoloop placement, gastric wall traction, or gastric volume reduction. Both groups will receive the same optimized lifestyle intervention and follow-up schedule. 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.

Being tested
Endoscopic Radial Compression Gastroplasty, Optimized Lifestyle Intervention (OLI), Sham Endoscopic Procedure
Keywords
Endoscopic gastroplasty, Endoscopic bariatric therapy, Weight loss, Overweight, Gastric volume reduction, Chinese, Obesity
Medical subject headings
Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Weight Loss, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Radial Compression GastroplastyProcedure or surgery

    Sutureless endoscopic gastric volume reduction using a novel clip-and-endoloop apposition system; performed under general anesthesia or deep sedation; standard perioperative care.

  • Optimized Lifestyle Intervention (OLI)Behavioural

    Structured nutrition counseling, calorie deficit plan, physical activity prescription per regional guidelines, and behavioral support; visit frequency matched to the ERCG arm.

  • Sham Endoscopic ProcedureProcedure or surgery

    A sham upper gastrointestinal endoscopic procedure performed under the same anesthesia strategy and procedural setting as ERCG. The procedure includes routine examination of the esophagus, stomach, and duodenum and may include non-therapeutic maneuvers such as insufflation, suction, and irrigation. No clips or endoloops are deployed, and no gastric wall traction or gastric volume-reduction procedure is performed. The total procedure-related duration is approximately 25 minutes.

Study groups in NCT07237750
Study groupRoleWhat they receive
ERCG + OLIExperimentalSutureless endoscopic gastric volume reduction using a clip-and-loop apposition system under non-intubated general anesthesia, plus standardized OLI (dietary counseling, calorie deficit, physical activity prescription, and behavioral support) with visit frequency matched to the comparator.
Receives: Procedure: Endoscopic Radial Compression Gastroplasty; Behavioral: Optimized Lifestyle Intervention (OLI)
Sham Procedure + OLISham comparatorParticipants assigned to the control group will undergo a sham endoscopic procedure under the same anesthesia strategy and procedural setting as the ERCG group. The sham procedure will include routine upper gastrointestinal endoscopy and non-therapeutic maneuvers, such as insufflation, suction, and irrigation, with a total procedure-related duration of approximately 25 minutes. No endoscopic clips or endoloops will be deployed, and no gastric wall traction or gastric volume-reduction procedure will be performed. Participants will subsequently receive the same optimized lifestyle intervention and follow-up schedule as the ERCG group.
Receives: Behavioral: Optimized Lifestyle Intervention (OLI); Procedure: Sham Endoscopic Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Total Body Weight Loss (%TBWL)

    Percentage total weight loss at 12 weeks will be calculated as: %TWL = [(baseline body weight - body weight at 12 weeks) / baseline body weight] × 100%. Body weight will be measured under standardized conditions.

    Measured: 12 weeks after the assigned procedure

  2. Clinical Responder Rate (CRR)

    The clinical response rate is defined as the proportion of participants achieving %TWL ≥5% at 12 weeks. Percentage total weight loss will be calculated as: %TWL = [(baseline body weight - body weight at 12 weeks) / baseline body weight] × 100%.

    Measured: 12 weeks after the assigned procedure

Secondary outcomes (11)
  1. Body Weight (kg)

    Weight measured on a calibrated scale under standardized conditions (light clothing, no shoes, preferably morning after ≥8h fasting).

    Measured: Baseline, 3 month, 6month

  2. Body Height (m)

    Standing height measured with a wall-mounted stadiometer, no shoes, heels together, Frankfurt plane horizontal.

    Measured: Baseline

  3. Percent Excess Body Weight Loss (%EBWL)

    %EBWL is calculated as [(Baseline weight - Follow-up weight) / (Baseline weight - Ideal weight)] × 100. Ideal weight is defined as the weight corresponding to a BMI of 23.9 kg/m². Weight is measured using a calibrated scale under standardized fasting conditions at each visit.

    Measured: 3 and 6 months post-intervention

  4. Change in BMI (kg/m²)

    BMI will be calculated as weight (kg) divided by height squared (m²).

    Measured: 3 and 6 months post-intervention

  5. Glycated Hemoglobin (HbA1c)

    HbA1c will be measured using standard laboratory methods. Values at each visit and changes from baseline will be summarized.

    Measured: Baseline, 3 and 6 months

  6. Adverse Events (AEs/SAEs) Related to Procedure

    Number and proportion of participants with device-/procedure-related AEs/SAEs, graded by Clavien-Dindo and per FDA/ISO definitions.

    Measured: Baseline, 3 and 6 months

  7. GERD-Q Total Score

    Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score, validated 6-item instrument. Higher scores indicate more severe reflux symptoms.

    Measured: Baseline, 3, and 6 months

  8. Postoperative Pain (VAS/NRS)

    Patient-reported pain intensity using a 0-10 scale (0=no pain, 10=worst imaginable pain). Assessed at rest.

    Measured: 6 hours, 24 hours, and 7 days

  9. Postoperative Nausea Score

    Patient-reported nausea severity using a 0-10 numeric rating scale (0=no nausea, 10=worst nausea).

    Measured: 6 hours, 24 hours, and 7 days

  10. Total Cholesterol

    Total cholesterol will be measured after an overnight fast using standard laboratory methods. Values at each visit and changes from baseline will be summarized.

    Measured: Baseline, 3 and 6 months

  11. Low-Density Lipoprotein Cholesterol (LDL-C)

    LDL-C will be measured directly or calculated using standard methods. Values at each visit and changes from baseline will be summarized.

    Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start13 Mar 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237750
Sponsor's protocol ID
307-2026-iWAIST-RCT
Acronym
iWAIST-RCT
Status last verified
Oct 2026
First submitted
16 Sep 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Radial Compression Gastroplasty and Optimized Lifestyle Intervention (OLI) in people with Overweight and/or Obesity and Metabolic Syndrome, run by Liu Yan at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Liu, M.D. PH.D. (+8601066947300, 13911798288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Total Body Weight Loss (%TBWL) (time frame: 12 weeks after the assigned procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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