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 range18 Years

SexALL

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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)

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

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