Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06015607

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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Polyps Colorectal

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Emre Gorgun, MD

CONTACT

[email protected]

1-800-223-2273

Emre Gorgun, MD

PRINCIPAL_INVESTIGATOR

Joshua Sommovilla, MD

SUB_INVESTIGATOR

Leonardo De Castro Dureas, MD

SUB_INVESTIGATOR

Rita Brienza

CONTACT

[email protected]

1-800-223-2273

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control (via ESD using standard of care)

Device

Polyp removal via ESD using standard of care

GripTract

Device

Polyp removal via ESD using GripTract

Primary outcomes

  1. Total Number of Device-Attributable Major Adverse Events

    Time frame: Enrollment to 30 days

    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.

  2. Total Number of Device-Attributable Minor Adverse Events

    Time frame: Enrollment to 30 days

    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.

Secondary outcomes

  1. Total Intervention Time

    Time frame: 4 hours

    Total Intervention Time from the start of submucosal injection through the end of dissection.

  2. Dissection Time

    Time frame: 3 hours

    Time from first incision of polyp removal (following circumferential incision) through end of polyp removal.

  3. Area of tissue removed

    Time frame: 4 hours

    Dimensional measurement of resected tissue

  4. En bloc removal

    Time frame: 4 hours

    Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc

  5. Average Physician Feedback Score

    Time frame: 4 hours

    Average score (Likert scale, 0-10) from seven different grading elements comparing the use of GripTract to the standard of care.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Gorgun, MD

CONTACT

[email protected]

1-800-223-2273

Rita Brienza

CONTACT

[email protected]

1-800-223-2273

Sponsors and collaborators

Lead sponsor

Actuated Medical, Inc.

Industry

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.