Polyps ColorectalNCT06015607
Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
A study testing GripTract in people with Polyps Colorectal, run by Actuated Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Polyps Colorectal
- What is being tested?
- GripTract
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Emre Gorgun, MD, 1-800-223-2273, gorgune@ccf.org
Rita Brienza, 1-800-223-2273, brienzr@ccf.org
About this study
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:
- How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care?
- How is the procedure time affected?
- Is the ability to resect the tissue en bloc affected?
- What is the user feedback on the device performance?
- Conditions
- Polyps Colorectal
- Being tested
- Control (via ESD using standard of care), GripTract
- Keywords
- endoscopic submucosal dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (via ESD using standard of care)Device
Polyp removal via ESD using standard of care
GripTractDevice
Polyp removal via ESD using GripTract
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care for removal of polyps during endoscopic submucosal disection (ESD). Receives: 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). Receives: Device: GripTract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Enrollment to 30 days
Secondary outcomes (5)
Total Intervention Time
Total Intervention Time from the start of submucosal injection through the end of dissection.
Measured: 4 hours
Dissection Time
Time from first incision of polyp removal (following circumferential incision) through end of polyp removal.
Measured: 3 hours
Area of tissue removed
Dimensional measurement of resected tissue
Measured: 4 hours
En bloc removal
Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc
Measured: 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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start11 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyps ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actuated Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Emre Gorgun, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015607
- Sponsor's protocol ID
- 1100794721
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
- ClinicalTrials.gov ID
- NCT06015607
- Acronym / sponsor ID
- 1100794721
- Conditions
- Polyps Colorectal
- Keywords
- endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Actuated Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care?
- How is the procedure time affected?
- Is the ability to resect the tissue en bloc affected?
- What is the user feedback on the device performance?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Control (via ESD using standard of care)Standard of care for removal of polyps during endoscopic submucosal disection (ESD). |
| GripTract | Experimental | Device: GripTractGripTract Endoscopic Tissue Manipulator will be installed on the endoscope and used to assist with removal of polyps during endoscopic submucosal disection (ESD). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (via ESD using standard of care)Polyp removal via ESD using standard of care | Device | Control |
| GripTractPolyp removal via ESD using GripTract | Device | GripTract |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emre Gorgun, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GripTract in people with Polyps Colorectal, run by Actuated Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Gorgun, MD (1-800-223-2273, gorgune@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Device-Attributable Major Adverse Events (time frame: Enrollment to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.