Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT07090005
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
Sponsor:
Nitinotes Surgical Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESG
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: