A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
NCT ID: NCT07219537
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-03-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Healthy
20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.
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.
With Disease
10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Guillermo Tearney
Principal Investigator
Principal Investigators
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Guillermo Tearney, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022P001154
Identifier Type: -
Identifier Source: org_study_id