CompletedNot Applicable

Safe Anastomosis Feasibility Study

Belgium, France27 participantsStarted 2019-12-18

Plain-language summary

A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer

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.

Exclusion criteria

. Patient with inflammatory bowel disease
. Known allergy to nickel or other components of the Colovac+ kit
. Pregnant or nursing female subject
. Concomitant major surgical procedure in combination with Colorectal resection (i.e. hepatectomy)
. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
. COVID-19 positive (active infection) based on test within 72 hours prior to surgery
. Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
. Immunodeficiency (CD4+ count \< 500 CU MM)

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

To measure the incidence of serious adverse events related to using the device

Timeframe: 3 months

Trial details

NCT IDNCT05180565

SponsorSafeHeal Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

View on ClinicalTrials.gov More Colorectal Cancer trials