Lower GI imaging with a tethered camera capsule
Official title: Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Run by Massachusetts General Hospital · NCT07219537 · Data updated 2026-11-12
This test tries a small camera capsule on a string that takes pictures of the lower gut without sedation for adults who are healthy or who have Lynch syndrome, Crohn's disease, or other inflammatory bowel diseases.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 27, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07219537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 who can give consent, tolerate bowel prep, and are either healthy or have a confirmed diagnosis of Lynch syndrome or report no known lower GI disease (or had a normal colonoscopy within the past 24 months) are ideal candidates.
✕Probably not a fit
People with prior colorectal or anorectal surgery, colonic strictures, diverticulosis/diverticulitis, colorectal cancer, bleeding disorders, use of most anticoagulants, pregnancy, or contraindications to bowel prep are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Investigators will insert a vitamin-sized tethered capsule into the lower gastrointestinal tract and advance it upward using a motorized slow spiral motion while it records optical coherence tomography (OCT) images in real time. The capsule remains attached to a string so it can be controlled and retrieved without sedation. Participants follow a standard bowel preparation before the procedure to clear the colon for imaging. The approach is being studied as a feasibility tool to capture structural images of the lower colon and rectum without traditional endoscopy.
Why it matters
Potential benefit: If successful, this could offer a lower-cost, sedation-free way to image the lower colon and rectum, making screening or surveillance more comfortable and accessible.
How similar studies have gone: Tethered capsule imaging approaches have shown feasibility in the esophagus, but retrograde OCT imaging of the lower GI tract is relatively novel and remains at the feasibility stage.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Guillermo Tearney, M.D., PhD — Massachusetts General Hospital
- Study coordinator: Nitasha Bhat, M.D.
- Email: Tearneylabtrials@partners.org
- Phone: 617-643-6092
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.