Lynch SyndromeNCT07219537
A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
A study testing Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract in people with Lynch Syndrome and Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 Dec 2028
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nitasha Bhat, MD, 617-643-6092, Tearneylabtrials@partners.org
About this study
Official title: Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
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.
- Conditions
- Lynch Syndrome, Crohn Disease, Inflammatory Bowel Diseases, Healthy
- Being tested
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tractDevice
30 participants will be enrolled in this study. All consented participants will receive the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | 20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH. Receives: Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract |
| With Disease | Experimental | 10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH. Receives: Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the R-TCE capsule to acquire quality images of the lower GI tract
Measured: Imaging data is collected during the study procedure and analyzed within one year of collection.
Secondary outcomes (1)
Tolerability of the R-TCE Capsule in an unsedated participant
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start27 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, M.D., PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219537
- Sponsor's protocol ID
- 2022P001154
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
- ClinicalTrials.gov ID
- NCT07219537
- Acronym / sponsor ID
- 2022P001154
- Conditions
- Lynch Syndrome, Crohn Disease, Inflammatory Bowel Diseases, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Dana-Farber Cancer Institute
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Oct 2025 (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 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
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH. |
| With Disease | Experimental | Device: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract30 participants will be enrolled in this study. All consented participants will receive the same intervention. | Device | Healthy, With Disease |
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.
1 secondary outcome
Tolerability of the R-TCE Capsule in an unsedated participant
Time frame: Day 1
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 16 Dec 2025.
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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.
Guillermo Tearney, M.D., PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract in people with Lynch Syndrome and Crohn Disease, run by Massachusetts General Hospital 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 5 inclusion and 12 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 16 Dec 2025. 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 Nitasha Bhat, M.D. (617-643-6092, Tearneylabtrials@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 16 Dec 2025.