Crohn Disease · Healthy · Inflammatory Bowel Diseases · Lynch Syndrome
Lower gastrointestinal imaging with a Retro-TCE capsule device
This pilot study is testing whether a tethered capsule device can obtain quality lower gastrointestinal images and be tolerated without sedation in healthy adults and adults with specified gastrointestinal conditions.
Registry title: A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
- Design
- Non Randomized
- Central study contact
- Nitasha Bhat, M.D.617-643-6092Tearneylabtrials@partners.org
- Sponsor
- Massachusetts General Hospital
Research question
Can the Retrograde Tethered Capsule Endomicroscope acquire quality images of the lower gastrointestinal tract, and how tolerable is the unsedated procedure?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study plans to enroll 20 healthy adults without pre-existing gastrointestinal disorders.
- The disease arm is described as enrolling 10 adults with confirmed Lynch syndrome, Crohn disease, or inflammatory bowel disease.
- Participants must be able to provide informed consent and follow bowel-preparation instructions.
Participation overview
What participation may involve
Participants undergo lower gastrointestinal imaging while unsedated using the tethered capsule device. The study evaluates image quality and asks participants to report comfort during the procedure. What participation may involve: - Participants must follow bowel-preparation instructions. - The tethered capsule is inserted into the lower gastrointestinal tract and advanced upward through a slow spiral motion while connected to an imaging system. - Imaging is performed without sedation, and the system displays and saves images in real time. - The study team asks participants about comfort throughout the procedure and records tolerability on a 0-to-10 scale, with 0 most tolerable and 10 least tolerable.
Study interventions
What participants may receive or do
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract: All consented participants receive the imaging intervention. A capsule about the size of a supplement is attached to a string and motor, inserted into the lower gastrointestinal tract, advanced upward in a slow spiral, and connected to a system that displays and saves images in real time.
Study design
How the comparison works
This is a non-randomized, open-label device-feasibility study with parallel healthy and disease groups. Both groups receive the same capsule imaging intervention. The study is non-randomized, so participants are not assigned to groups by chance. The study has no masking, meaning the registry does not describe participants or researchers as blinded to the intervention. The registry describes two experimental groups but no separate control or comparator intervention; all consented participants receive the same device intervention. The registry does not describe a placebo or sham procedure, and it states that all consented participants receive the same intervention.
Reported activities
Procedures and tests
- Bowel preparation is required, because participants must be able to follow the preparation instructions.
- A tethered capsule is inserted into the lower gastrointestinal tract and advanced upward with a motor-driven slow spiral motion.
- The connected imaging system displays and saves lower gastrointestinal images in real time.
- Participants remain unsedated during imaging.
- Participants report comfort during the procedure and score tolerability from 0 to 10.
- Screening may involve confirming either a colonoscopy within the previous 24 months without abnormalities or the specified absence of gastrointestinal symptoms and known lower-tract disease or abnormality for Rally volunteers.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be at least 18 years old.
- The eligibility criteria state that participants must be healthy or have a confirmed diagnosis of Lynch syndrome.
- Participants must be able to provide informed consent.
- Participants must be able to follow bowel-preparation instructions.
- Participants must have had a colonoscopy within the previous 24 months that found no abnormalities, or report no gastrointestinal symptoms or known lower gastrointestinal disease or abnormality and volunteer through Rally.
Possible reasons someone may not be able to join
- People older than 75 are excluded.
- A history or current diagnosis of narrowing in the colon or anus excludes participation.
- A current bleeding disorder excludes participation.
- Current use of medication that interferes with blood clotting excludes participation, except for low-dose aspirin.
- A history or current diagnosis of colorectal cancer excludes participation.
- A history or current diagnosis of diverticulosis or diverticulitis excludes participation.
- Any previous surgery involving the anus, rectum, or colon excludes participation.
- A history of volvulus or torsion excludes participation.
- Pregnant people are excluded.
- A contraindication to bowel preparation or colonoscopy excludes participation.
- Severe acute inflammatory bowel disease excludes participation.
- Large hemorrhoids, hemorrhoidal bleeding, or hemorrhoid banding excludes participation.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required or whether follow-up visits occur.
- The registry does not report how long an individual participant remains in the study.
- The registry does not explain whether participants with gastrointestinal disease can continue their usual medications or other treatments.
- The registry excludes current use of drugs that interfere with coagulation, except low-dose aspirin, but does not state whether stopping such drugs is permitted or required.
- The registry does not describe what care is available if discomfort or a complication occurs during the procedure.
- Eligibility refers to a prior colonoscopy or an alternative symptom-history pathway, but the registry does not clearly state whether the study requires another colonoscopy or other endoscopic procedure.
- The registry does not state which study-related or medical costs are covered or billed to insurance.
- The registry does not state whether participants are compensated.
- The registry does not state whether transportation, parking, lodging, or other travel expenses are supported.
- The disease arm includes Lynch syndrome, Crohn disease, and inflammatory bowel disease, while the inclusion criteria mention only healthy participants or people with confirmed Lynch syndrome.
Before contacting the site
Questions for the study team
- How many in-person visits and follow-up contacts are required, and how long does participation last?
- What bowel preparation is required, and when must it begin?
- Does participation require a new colonoscopy or any additional endoscopic procedure?
- Are people with Crohn disease or another inflammatory bowel disease currently eligible for the disease arm?
- Which medications may be continued, and are any medications required to be stopped before the procedure?
- What safety monitoring and medical care are available if the capsule cannot advance as planned or causes significant discomfort?
- Which costs are covered, is anything billed to insurance, and are compensation or travel support available?
Before changing care
Questions for your gastroenterologist
- Would my current gastrointestinal disease be stable enough for an unsedated lower-tract imaging procedure?
- Could the required bowel preparation or capsule procedure pose concerns given my disease history, anatomy, or prior surgeries?
- How should my current medicines, especially drugs affecting blood clotting, be coordinated with the study team?
- What approved imaging or monitoring alternatives should I understand before considering this research procedure?
- If I contact the study, how should you and the research team coordinate my usual care and any findings from the imaging?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Massachusetts General Hospital
- Organization class
- Other
- Organization study ID
- 2022P001154
- Lead sponsor
- Massachusetts General Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Device Feasibility
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Healthy
20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.
Interventions: Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
Experimental
With Disease
10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH.
Interventions: Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
Interventions
Device
Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
30 participants will be enrolled in this study. All consented participants will receive the same intervention.
Eligibility
18 Years–75 Years
All
Accepted
Inclusion criteria (5)
- Are 18 years of age or older.Registry-derived · unreviewed
- Are healthy or with a confirmed diagnosis of Lynch SyndromeRegistry-derived · unreviewed
- Are capable of giving informed consent.Registry-derived · unreviewed
- Are able to follow bowel prep instructionsRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (12)
- Who are over 75 years of age or olderRegistry-derived · unreviewed
- With a history or current diagnosis of colonic and/or anal stricturesRegistry-derived · unreviewed
- With a current diagnosis of any bleeding disordersRegistry-derived · unreviewed
- Who currently use drugs that interfere with coagulation (excluding low-dose aspirin)Registry-derived · unreviewed
- With a history or current diagnosis of colorectal cancerRegistry-derived · unreviewed
- With a history or current diagnosis of diverticulosis or diverticulitisRegistry-derived · unreviewed
- With any prior anorectal, colorectal, or colonic surgeryRegistry-derived · unreviewed
- With a history of volvulus or torsionRegistry-derived · unreviewed
- Who are pregnantRegistry-derived · unreviewed
- With contraindications to bowel prep or colonoscopyRegistry-derived · unreviewed
- With severe acute inflammatory bowel diseaseRegistry-derived · unreviewed
- With large hemorrhoids or hemorrhoidal bleeding or bandingRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Ability of the R-TCE capsule to acquire quality images of the lower GI tract
Time frame: Imaging data is collected during the study procedure and analyzed within one year of collection.
Secondary outcome
Tolerability of the R-TCE Capsule in an unsedated participant
Time frame: Day 1
R-TCE imaging will be conducted in unsedated participants. The study team will ask the participants about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0 to 10. With 0 being the most tolerable to10 being the least.
Recruiting locations in the United States
Massachusetts General Hospital
RecruitingBoston, Massachusetts, 02114, United States
Nitasha Bhat, MD617-643-6092Tearneylabtrials@partners.org
Central study contacts
Registry dates
- First posted
- Oct 22, 2025
- Primary completion
- Dec 31, 2027
- Overall completion
- Dec 31, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.