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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nitinotes Surgical Ltd.
Study ID
NCT07090005
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Nov 14, 2025
Status verified
Dec 2025
Primary completion
Jun 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: OverStitch Endoscopic Suturing System
    Description: The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.

Primary Outcome Measure

Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B. [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Lenox Hill Hospital | Northwell HealthNew YorkNew York10075
Steven Shamah, MD
[email protected]
973-699-9328
Steven Shamah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cedars Sinai Medical Center· Los Angeles, CALenox Hill Hospital | Northwell Health· New York, NY

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