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Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients | Clinical Trials | Clareo Health

RECRUITINGNA

Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients

Comparing the Efficacy and Safety of the EndoZipTM System and Apollo Endoscopic Sleeve Gastroplasty (ESG), Followed by Behavioral Modifications, in Obese Patients Who Have Not Achieved Weight Reduction Through Non-surgical Methods.

NCT07090005•Nitinotes Surgical Ltd.

View on ClinicalTrials.gov

Summary

evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.

Detailed Description

randomized, multicenter, prospective, two-arms, blinded, clinical study will include up to 184 patients (up to 30 patients per site), aimed at evaluating the safety and effectiveness of the EndoZip system procedure, compared to the Apollo ESG procedure, in obese patients who failed to reduce weight with non-surgical weight-loss methods. Patients will be enrolled at up to 10 clinical sites in US and Europe. Patients who meet the eligibility criteria will be follow up for 12 months.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 21-65
•2. BMI ≥ 30 and ≤50 kg/m².
•3. Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
•4. History of failure with non-surgical weight-loss methods.
•5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program.
•6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
•7. Ability to give informed consent.
•8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
•9. \*\*\* There will be a quota for at least a) 46 patients with hypertension treated with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment , b) 46 patients with type II diabetes mellitus on oral agents only with HgbA1c ≤ 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. Thus the cohort of 184 patients will be stratified into four groups (Obesity, Obesity \& HTN, Obesity \& DM, obesity \&HTN \&DM) and block randomized.

Exclusion Criteria

•1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
•2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
•3. Prior open or laparoscopic bariatric surgery.
•4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
•5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
•6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
•7. A gastric mass or gastric polyps \> 1 cm in size.
•8. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
•9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
•10. Achalasia or any other severe esophageal motility disorder
+24 more criteria

Locations (2)

Cedars Sinai Medical Center

Los Angeles, California, United States

Lenox Hill Hospital | Northwell Health

New York, New York, United States

Key Dates

Start Date

November 14, 2025

Primary Completion Date

June 1, 2027

Completion Date

July 1, 2027

Last Updated

January 21, 2026

Enrollment

184

ESTIMATED participants

Conditions

ObesityOverweight

Interventions

EndoZip System

DEVICE

OverStitch Endoscopic Suturing System (ESG)

DEVICE

Contacts

Ravit Peled

CONTACT

+972526145354 ravit@nitinotesurgical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients

Inclusion Criteria

Exclusion Criteria

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