Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
Recruiting now · Not applicable
Conditions studied: Colorectal Cancer
In brief
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Key facts
- Study ID
- NCT07337590
- Run by
- Exero Medical Ltd.
- People needed
- 80
- Starts
- 2026-03-10
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Interventional Cohort
- 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.
- Historical Cohort
- 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.
You may not qualify if…
- Interventional Cohort
- 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
- LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
Where it is running
- University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Bryan Medical Center — Lincoln, Nebraska, United States (enrolling)
- Weill Cornell Medicine Colon and Rectal Surgery — New York, New York, United States (enrolling)
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)
- Department of Colon and Rectal Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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