Real-time xBar monitoring to protect colorectal anastomoses

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

This study will try using the xBar device placed during low anterior resection to see if real-time monitoring improves recovery, lowers complications, and reduces stoma use in adults with colorectal cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Exero Medical Ltd. (Industry-sponsored)
• Locations: 4 sites (Louisville, Kentucky and 3 other locations)
• Trial ID: NCT07337590 on ClinicalTrials.gov

What this trial studies

This interventional study places the xBar system during elective low anterior resection for colorectal cancer and follows patients through recovery. Patients who receive xBar will be compared to a historical control group matched to the same inclusion/exclusion criteria. Primary comparisons include overall morbidity, healthcare utilization costs, and stoma utilization over the follow-up period. The xBar platform is designed for postoperative sensing and to fit within existing clinical workflow without changing standard surgical technique.

Who should consider this trial

Good fit: Adults aged 21 or older scheduled for elective low anterior resection for colorectal cancer with an expected anastomosis within 10 cm of the anal verge, intraoperative drain use, and ability to consent and complete follow-up.

Not a fit: Patients with benign disease, contraindications to anesthesia, pregnancy or lactation, emergency surgeries, anastomoses located more than 10 cm from the anal verge, or who do not have a drain placed during surgery are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, xBar could detect anastomotic problems earlier, reduce complication rates and temporary stoma use, and lower related healthcare costs.

How similar studies have performed: Real-time postoperative sensing for anastomotic leaks has shown promise in small device-specific studies and xBar was considered non-significant risk in prior work, but large randomized evidence is limited.

Eligibility criteria

Inclusion Criteria:

Interventional Cohort

1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
2. Expected anastomosis within 10 cm from the anal verge
3. Usage of drain during the surgery (to be confirmed during the surgery)
4. Willing and able to comply with the study follow up and able and agree to provide informed consent.

Historical Cohort

1. Adults aged ≥21 years at the time of surgery.
2. Underwent a low anterior resection (LAR) for malignant colorectal disease.
3. 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:

Interventional Cohort

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

1\. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).

Where this trial is running

Louisville, Kentucky and 3 other locations

• University of Louisville Hospital — Louisville, Kentucky, United States (Not_yet_recruiting)
• Weill Cornell Medicine Colon and Rectal Surgery — New York, New York, United States (Recruiting)
• Department of Colon and Rectal Surgery — New York, New York, United States (Not_yet_recruiting)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Ilana Fishman

Conditions Colorectal Cancer