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Recruiting NCT06015607

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

No phase Interventional Polyps Colorectal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control (via ESD using standard of care), GripTract.
Who it may be relevant to
Registry conditions: Polyps Colorectal. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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?

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Total Intervention Time [Time frame: 4 hours]
  • Dissection Time [Time frame: 3 hours]
  • Area of tissue removed [Time frame: 4 hours]
  • En bloc removal [Time frame: 4 hours]
  • Average Physician Feedback Score [Time frame: 4 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06015607 · 1100794721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗