Retro-TCE Capsule for Lower GI Tract Imaging

Overseen By Nitasha Bhat, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Coagulation drugs

Disqualifiers: Colorectal cancer, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new capsule device designed to photograph the lower gastrointestinal (GI) tract without sedation. The goal is to find a simple, affordable method to detect signs of disease in the lower GI tract. The trial includes two groups: one with healthy adults and another with adults diagnosed with conditions like Lynch Syndrome or Crohn's Disease. Ideal candidates for this trial are those who have had a colonoscopy in the last two years with no issues or those with no known GI tract problems. As an unphased trial, this study allows participants to contribute to innovative research that could simplify GI tract diagnostics.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use drugs that interfere with blood clotting, except for low-dose aspirin.

What prior data suggests that this capsule is safe for lower GI tract imaging?

Research has shown that devices like the one being tested are generally safe. Studies on similar systems, which use a small capsule on a string to capture images, have found that patients usually tolerate them well. These studies have examined various conditions, such as Barrett's esophagus, and have reported very few side effects.

The Retro-TCE Capsule being tested is a similar device designed to examine the lower part of the digestive system. It is noninvasive and doesn't require sedation, reducing the risk of complications. So far, it appears to be well-tolerated, and studies are monitoring for any possible side effects.

While specific data on this capsule's safety is not yet available, the technology it employs has been tested in other contexts with good results. This suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Retro-TCE Capsule because it offers a non-invasive way to image the lower GI tract, which could provide a more comfortable alternative to traditional methods like colonoscopies. The capsule is unique because it uses advanced imaging technology that can capture detailed images as it travels through the GI tract, potentially leading to earlier and more accurate diagnoses of conditions like Lynch Syndrome, Crohn's Disease, and Inflammatory Bowel Disease. This method could significantly improve patient experience by eliminating the need for sedation and recovery time associated with more invasive procedures.

What evidence suggests that the Retro-TCE Capsule is effective for lower GI tract imaging?

Research shows that the Retro-TCE Capsule, used by participants in this trial, is a promising tool for viewing the lower digestive tract. Studies indicate that this capsule can capture detailed, 3D images without sedating the patient. This method is less invasive than traditional procedures yet still provides clear images. Early results suggest it offers a safe and effective way to detect signs of disease in the digestive tract. While research on its use in the lower digestive tract continues to expand, the technology has already succeeded in similar applications in the upper digestive tract. ^{3 6 7 8 9}

Who Is on the Research Team?

Guillermo Tearney, M.D., PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Lynch Syndrome, Crohn's Disease, Inflammatory Bowel Disease, Colorectal Cancer or healthy subjects interested in contributing to medical research. Participants should be comfortable swallowing a capsule and having it maneuvered through their lower GI tract without sedation.

Inclusion Criteria

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

I am 18 years old or older.

Exclusion Criteria

I am currently taking medication that affects blood clotting, not including low-dose aspirin.

I have or had colorectal cancer.

With a history of volvulus or torsion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Procedure

Participants undergo imaging of the lower GI tract using the Retro-TCE capsule

45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Retro-TCE Capsule

Trial Overview The study is testing the feasibility of using a new device called an OCT-based Retrograde Tethered Capsule Endomicroscope to capture images inside the lower gastrointestinal (GI) tract. The device involves swallowing a capsule attached to a tether that transmits real-time images as it moves upward through the GI tract.

How Is the Trial Designed?

Group I: With Disease Experimental Treatment 1 Intervention

10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH.

Group II: Healthy Experimental Treatment 1 Intervention

20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Citations

1. medicaldevicenavigator.com medicaldevicenavigator.com/advancing_future_lower_gi_imaging_with_retro_tce/

Advancing the Future of Lower GI Tract Imaging: Pilot Study Launch ... The pilot study introducing the OCT-based Retro-TCE device holds promise for advancing imaging methods in diagnosing diseases of the lower GI tract.

2. smartpatients.com smartpatients.com/trials/NCT07219537

Pilot Study for Imaging the Lower Gastrointestinal Tract ... The investigators have developed an inexpensive tool to take pictures in the lower GI tract without sedation and to look for signs of disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3567218/

Tethered capsule endomicroscopy enables less-invasive ... This technique rapidly provides three-dimensional, microstructural images of the upper gastrointestinal tract in a simple and painless procedure.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8176642/

Tethered Capsule Endomicroscopy for unsedated ... Conclusions: TCE is a safe and feasible procedure for obtaining high-resolution microscopic images of the upper GI tract without endoscopic ...

5. researchgate.net researchgate.net/publication/389320946_C_URRENT_OPINION_Panenteric_capsule_endoscopy_in_gastrointestinal_bleeding_-time_to_change_old_habits

C URRENT OPINION Panenteric capsule endoscopy in ... Two retrospective studies and one recent prospective trial consistently show that when used in the workup of GI bleeding patients, PC is safe, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07219537

Pilot Study for Imaging the Lower Gastrointestinal Tract ... Also called a data safety and monitoring board, or DSMB. ... Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule.

7. withpower.com withpower.com/trial/phase-colorectal-neoplasms-hereditary-nonpolyposis-2-2023-26aec

Retro-TCE Capsule for Lower GI Tract Imaging This N/A medical study run by Massachusetts General Hospital is evaluating whether Retro-TCE Capsule will have tolerable side effects ...

8. aetna.com aetna.com/cpb/medical/data/500_599/0588.html

Capsule Endoscopy - Medical Clinical Policy Bulletins A noninvasive, diagnostic procedure that is designed to visualize the esophagus, stomach, small bowel or colon.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8715859/

Feasibility and safety of tethered capsule endomicroscopy ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi- ...