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

NCT07337590 | Recruiting DMC FDA Device

• 1 other identifier: CLP 04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

  Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.

  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)

  Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)

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

Secondary Outcomes (3)

• Number of Stoma-Free patients during the study follow up

  Time points 30 days, 90 days, 6 months and 12 months following the index surgery

• Sensitivity and specificity of xBar outcome

  As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.

• 1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome

  At timepoints of 30, 90 ,180 and 365 days following the index surgery

Other Outcomes (2)

• Tertiary Endpoint- Health Resource Utilization

  Post operative days 30, 90 and 6 months, 12 months

• Exploratory Endpoint-Clinical Teams Usability Feedback

  As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.]

Study Arms (2)

Interventional Cohort

EXPERIMENTAL

The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal.

Device: xBar™ System

Historical Control Cohort

NO INTERVENTION

A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.

Interventions

xBar™ System DEVICE

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.

Interventional Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Exero Medical Ltd.: lead

Study Sites (4)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Weill Cornell Medicine Colon and Rectal Surgery

New York, New York, 10021, United States

RECRUITING

Department of Colon and Rectal Surgery

New York, New York, 10075, United States

NOT YET RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Ilana Fishman

CONTACT

+972547545065; ilana.fishman@exeromedical.com

Ruth Stone

CONTACT

ruth.stone@exeromedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include two cohorts: * Interventional Cohort: Approximately 80 eligible subjects with colorectal cancer undergoing elective low anterior resection with anastomosis, without concomitant diversion, who meet all study inclusion criteria and none of the exclusion criteria. * Historical Control Cohort: A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 13, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)