๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-09

A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule (NCT07219537)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Massachusetts General Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (13 items).

Location: Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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
  • 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—