Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon

Conditions

• Polyps Colorectal

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Control (via ESD using standard of care) — DEVICE
  Polyp removal via ESD using standard of care
• GripTract — DEVICE
  Polyp removal via ESD using GripTract

Study Details

The goal of this clinical trial is to compare the safety and effectiveness of the GripTract GI Endoscopic Tissue Manipulator to the current standard of care for complex polypectomies in adults. The main questions it aims to answer are: 1. How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care? 2. How is the procedure time affected? 3. Is the ability to resect the tissue en bloc affected? 4. What is the user feedback on the device performance?

Key Dates

Start date

Jun 11, 2026

Status verified

Jun 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control
  Standard of care for removal of polyps during endoscopic submucosal disection (ESD).
• Experimental: GripTract
  GripTract Endoscopic Tissue Manipulator will be installed on the endoscope and used to assist with removal of polyps during endoscopic submucosal disection (ESD).

Primary Outcome Measure

Total Number of Device-Attributable Major Adverse Events [ Time Frame: Enrollment to 30 days ]

Central Contacts

• Emre Gorgun, MD
  1-800-223-2273
  [email protected]
• Rita Brienza
  1-800-223-2273
  [email protected]

Locations (1)

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