NCT07219537 A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
| NCT ID | NCT07219537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Lynch Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-03-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators have developed an inexpensive tool to take pictures in the lower GI tract without sedation and to look for signs of disease. The tool is a capsule, about the size of a fish oil or multi-vitamin supplement, attached to a string. The capsule and string are connected to a motor to allow the capsule to advance up the participant's lower GI tract. The capsule will be inserted into the participant's lower GI tract and advance upward via a slow spiral motion. The capsule is connected to an imaging system that saves and displays the images in real time.
Eligibility Criteria
Inclusion Criteria: * Are 18 years of age or older. * Are healthy or with a confirmed diagnosis of Lynch Syndrome * Are capable of giving informed consent. * Are able to follow bowel prep instructions * Had a colonoscopy 0-24 months prior that did not show any abnormalities or individuals who report no gastrointestinal symptoms and no knowledge of any lower GI tract disease or abnormality and volunteer through Rally. Exclusion Criteria: * Who are over 75 years of age or older * With a history or current diagnosis of colonic and/or anal strictures * With a current diagnosis of any bleeding disorders * Who currently use drugs that interfere with coagulation (excluding low-dose aspirin) * With a history or current diagnosis of colorectal cancer * With a history or current diagnosis of diverticulosis or diverticulitis * With any prior anorectal, colorectal, or colonic surgery * With a history of volvulus or torsion * Who are pregnant * With contraindications to bowel prep or colonoscopy * With severe acute inflammatory bowel disease * With large hemorrhoids or hemorrhoidal bleeding or banding
Contact & Investigator
Guillermo Tearney, M.D., PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07219537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lynch Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07219537 currently recruiting?
Yes, NCT07219537 is actively recruiting participants. Contact the research team at Tearneylabtrials@partners.org for enrollment information.
Where is the NCT07219537 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07219537 clinical trial?
NCT07219537 is sponsored by Massachusetts General Hospital. The principal investigator is Guillermo Tearney, M.D., PhD at Massachusetts General Hospital. The trial plans to enroll 30 participants.