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

NCT07090005 | Recruiting DMC FDA Device

• 1 other identifier: CL00020
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.

  12 months

• Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months

  12 months

Study Arms (2)

EndoZip System

EXPERIMENTAL

The EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach.

Device: EndoZip System

OverStitch Endoscopic Suturing System

ACTIVE COMPARATOR

Description: The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.

Device: OverStitch Endoscopic Suturing System (ESG)

Interventions

EndoZip System DEVICE

The EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach.

EndoZip System

OverStitch Endoscopic Suturing System (ESG) DEVICE

The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.

OverStitch Endoscopic Suturing System

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• BMI ≥ 30 and ≤50 kg/m².
• Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
• History of failure with non-surgical weight-loss methods.
• 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.
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
• Ability to give informed consent.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• \*\*\* 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.

You may not qualify if:

• History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
• Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
• Prior open or laparoscopic bariatric surgery.
• Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
• 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.
• 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.
• A gastric mass or gastric polyps \> 1 cm in size.
• A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• Achalasia or any other severe esophageal motility disorder
• Severe coagulopathy (INR \>1.5) or on anticoagulation therapy.
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ \> 9.
• Diabetics who are treated with GLP-1 and have lost 5% or more of their weight (%TBWL ≥ 5%).
• Patients who discontinued GLP-1 therapy and regained less than 80% of the weight they had lost prior to starting GLP-1 treatment and within 3 months of discontinued GLP-1 therapy.
• Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy

Sponsors & Collaborators

• Nitinotes Surgical Ltd.: lead

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

ACTIVE NOT RECRUITING

Lenox Hill Hospital | Northwell Health

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ravit Peled

CONTACT

+972526145354; ravit@nitinotesurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Dietitians and medical staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The EndoZip system is a single-use device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. The device is intended to be used in adult patients with obesity who have a body mass index (BMI) of 30-40 50 kg/m2 and who have not been able to lose weight or maintain weight loss through more conservative measures. The system uses an automated a minimally invasive approach to form wall-to-wall longitudinal attachments anterior and posterior stomach walls, creating multiple plications within.

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 29, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-12

Locations

US (2)