NCT07090005

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Nitinotes Surgical Ltd. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DEVICE	EndoZip System	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	OverStitch Endoscopic Suturing System (ESG)	The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2025-07-29
• Last updated: 2026-01-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study