RecruitingNot ApplicableNCT07337590

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

Sponsor

Exero Medical Ltd.

Enrollment

80 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

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

Eligibility

Min Age: 21 Years

Inclusion Criteria9

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.

Exclusion Criteria10

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).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICExBar™ System

Device: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols.