🏛️ Verified NIH Record • Updated 2026-07-02
Efficacy and Safety of the CG-100 Intraluminal Bypass Device (NCT04184973)
Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Colospan Ltd.
🩺 Plain-English Summary (8th-Grade Level)
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Who can join: Review the eligibility criteria below.
Location: University of California Irvine — Irvine, California
Age range: 22 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- University of California Irvine — Irvine, California
- Kaiser Permanente San Diego medical Center — San Diego, California
- Colorado University Anschutz Medical Campus — Aurora, Colorado
- Henry Ford Health System — Detroit, Michigan
- Lifespan & Brown Surgical Associates — Providence, Rhode Island
- University of Utah Health — Salt Lake City, Utah
- Asklepios — Hamburg,
- Soroka University Medical Center — Beersheba,
- Humanitas Research Hospital — Milan, Lombardy
- CHUV — Lausanne,
📞 Contact the Study Coordinator
Phone: +972-9-7672518
Email: boaz@colospan.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.