CompletedPhase 2

End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study

Belgium

Plain-language summary

the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis

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: * Patient age over 18 * Patient schedule for colonic surgery requiring E-t-E anastomosis * Patient is able to understand and to sign the Informed Consent Form Exclusion Criteria: * Patient has known allergy to Nickel * Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection * Patient on regular steroid medication * Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis * Patient following radiation (that compromised the anastomosis) * Patient who are undergoing a defunctioning stoma * Patient with contraindication to general anesthesia * Patient who is currently participating in other clinical trial * Patient who refuse consent

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

functioning anastomosis & no occurrence of adverse events related to device use

Timeframe: during hospitalization and until 3 months after discharge

Trial details

NCT IDNCT00497263

SponsorNiti Medical Technologies Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Colorectal Cancer trials

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.