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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental | 20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitasha Bhat, M.D. | Contact | 617-643-6092 | Tearneylabtrials@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, M.D., PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005759 | Gastroenteritis |
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