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

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?

Study Overview

• Status: Recruiting
• Conditions: Polyps Colorectal
• Intervention / Treatment: Device: Control (via ESD using standard of care); Device: GripTract

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emre Gorgun, MD; Phone Number: 1-800-223-2273; Email: gorgune@ccf.org
• Study Contact Backup: Name: Rita Brienza; Phone Number: 1-800-223-2273; Email: brienzr@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Emre Gorgun, MD
      • Contact: Emre Gorgun, MD; Phone Number: 1-800-223-2273; Email: gorgune@ccf.org
      • Contact: Rita Brienza; Phone Number: 1-800-223-2273; Email: brienzr@ccf.org
      • Sub-Investigator: Leonardo De Castro Dureas, MD
      • Sub-Investigator: Joshua Sommovilla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
• Patients capable of giving informed consent English and lacking cognitive impairment
• No medical contraindication to endoscopic mucosal resection or endoscopic submucosal dissection

Exclusion Criteria:

• Patients less than 21 years of age
• Any contraindication to colonoscopy with due to subject's colon anatomy (i.e., structure)
• History of open or laparoscopic colorectal surgery
• History of Inflammatory Bowel Disease
• Patients requiring multiple polyp removals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard of care for removal of polyps during endoscopic submucosal disection (ESD).	Device: Control (via ESD using standard of care); Polyp removal via ESD using standard of care
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).	Device: GripTract; Polyp removal via ESD using GripTract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Device-Attributable Major Adverse Events	Subjects will receive follow-ups at 24 hrs, 72 hours, and 30 days post intervention to monitor adverse events. Major adverse events are those that necessitate non-endoscopic intervention.	Enrollment to 30 days
Total Number of Device-Attributable Minor Adverse Events	Subjects will receive follow-ups at 24 hrs, 72 hrs, and 30 days post intervention to monitor adverse events. Minor adverse events are those that can be successfully addressed endoscopically.	Enrollment to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Intervention Time	Total Intervention Time from the start of submucosal injection through the end of dissection.	4 hours
Dissection Time	Time from first incision of polyp removal (following circumferential incision) through end of polyp removal.	3 hours
Area of tissue removed	Dimensional measurement of resected tissue	4 hours
En bloc removal	Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc	4 hours
Average Physician Feedback Score	Average score (Likert scale, 0-10) from seven different grading elements comparing the use of GripTract to the standard of care.	4 hours

Collaborators and Investigators

• Sponsor: Actuated Medical, Inc.
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Emre Gorgun, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): June 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: endoscopic submucosal dissection
• Other Study ID Numbers: 1100794721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No