A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Not applicable · Testing Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to… · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract (a device) to check whether a device is practical to use. Condition(s) listed: Lynch Syndrome, Crohn Disease and Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Are 18 years of age or older.
- Are healthy or with a confirmed diagnosis of Lynch Syndrome
- Are capable of giving informed consent.
Plus 2 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2023-03-27.
- Main results expected around 2027-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Ability of the R-TCE capsule to acquire quality images of the lower GI tract (Imaging data is collected during the study procedure and analyzed within one year of collection.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Lynch Syndrome; Crohn Disease; Inflammatory Bowel Diseases; Healthy |
| Lead sponsor | Massachusetts General Hospital |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust; Dana-Farber Cancer Institute |
| Enrollment | 30 (estimated) |
| Start date | 2023-03-27 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2025-10-22 |
| Last updated | 2025-12-16 |
| Official title | Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule |
| ClinicalTrials.gov ID | NCT07219537 |
Interventions
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract (Device)
30 participants will be enrolled in this study. All consented participants will receive the same intervention.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.