CompletedNot Applicable

SafeHeal Diverting Ileostomy Pivotal Study

United States, Belgium, France132 participantsStarted 2024-01-01

Plain-language summary

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients (18 years of age or older)
. Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
. Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion criteria

. History of left colitis
. Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Early anastomotic complications

Timeframe: 9 months

Overall major complications

Timeframe: 9 months

Trial details

NCT IDNCT06152276

SponsorSafeHeal Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01-30

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