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

NCT06015607 | Recruiting FDA Device

• 1 other identifier: 1100794721
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care?
2. 2.How is the procedure time affected?
3. 3.Is the ability to resect the tissue en bloc affected?
4. 4.What is the user feedback on the device performance?

Conditions

Polyps Colorectal

Keywords

endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Total Intervention Time

  4 hours

• Dissection Time

  3 hours

• Area of tissue removed

  4 hours

• En bloc removal

  4 hours

• Average Physician Feedback Score

  4 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care for removal of polyps during endoscopic submucosal disection (ESD).

Device: Control (via ESD using standard of care)

GripTract

EXPERIMENTAL

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

Interventions

GripTract DEVICE

Polyp removal via ESD using GripTract

GripTract

Control (via ESD using standard of care) DEVICE

Polyp removal via ESD using standard of care

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actuated Medical, Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Emre Gorgun, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emre Gorgun, MD

CONTACT

1-800-223-2273; gorgune@ccf.org

Rita Brienza

CONTACT

1-800-223-2273; brienzr@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: June 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)