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.
Nitinotes Surgical Ltd.
Summary
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
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 range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
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 inv…
Interventions
- DeviceEndoZip 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.
- DeviceOverStitch Endoscopic Suturing System (ESG)
The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.
Locations (2)
- Cedars Sinai Medical CenterLos Angeles, California
- Lenox Hill Hospital | Northwell HealthNew York, New York