Recruiting

GripTract GI

Sponsor:

Actuated Medical, Inc.

Code:

NCT06015607

Conditions

Polyps Colorectal

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Control (via ESD using standard of care)

GripTract

Study Details

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. 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?

Conditions

Polyps Colorectal

Study ID

NCT06015607

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Control (via ESD using standard of care)

Polyp removal via ESD using standard of care

GripTract

Polyp removal via ESD using GripTract

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Emre Gorgun, MD

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

Rita Brienza

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

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emre Gorgun, MD

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

Rita Brienza

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

Principal Investigator:

Emre Gorgun, MD

More Information

Sponsor

Actuated Medical, Inc.

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • endoscopic submucosal dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Actuated Medical, Inc. on 2026-06-15.