RecruitingNot Applicable

Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

United States80 participantsStarted 2026-03-10

Plain-language summary

Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.

Who can participate

Age range21 Years

SexALL

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

Inclusion criteria

✓. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
✓. Expected anastomosis within 10 cm from the anal verge
✓. Usage of drain during the surgery (to be confirmed during the surgery)
✓. Willing and able to comply with the study follow up and able and agree to provide informed consent.
✓. Adults aged ≥21 years at the time of surgery.
✓. Underwent a low anterior resection (LAR) for malignant colorectal disease.
✓. Documented colorectal anastomosis located \<10cm from the anal verge, or documented tumor \<10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.

Exclusion criteria

✕. Subjects with benign disease
✕. Contraindication for surgery and/or general anesthesia.
✕. Known pregnancy or lactation.
✕. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
✕. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
✕. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
✕. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
✕. Participation in another interventional study during the xBar system usage. Historical Cohort

What they're measuring

Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts

Timeframe: At the time points of 30 and 90 days following index surgery

Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)

Timeframe: from the date of index surgery up to 365 days following the index surgery

Trial details

NCT IDNCT07337590

SponsorExero Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Ilana Fishman

+972547545065 ilana.fishman@exeromedical.com

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