Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar (ASSURE)

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: xBar™ System

Detailed Description

The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.

The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Fishman; Phone Number: +972547545065; Email: ilana.fishman@exeromedical.com
• Study Contact Backup: Name: Ruth Stone; Email: ruth.stone@exeromedical.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Hospital
      • Contact: Kiel Carson Butterfield; Email: kiel.carsonbutterfield@louisville.edu
      • Principal Investigator: Sandra Kavalukas, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Jodie Frost; Email: jfrost17@jhmi.edu
      • Principal Investigator: Andrea Bafford, MD, FACS, FASCRS
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Bryan Medical Center
      • Contact: Kristin Williams; Email: kristin.williams@bryanhealth.org
      • Principal Investigator: Michael Jobst, MD
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine Colon and Rectal Surgery
      • Contact: KM Muktasid; Phone Number: 646-962-2789; Email: kmm4010@med.cornell.edu
      • Principal Investigator: Mehraneh D Jafari, MD
    • New York, New York, United States, 10075
      • Not yet recruiting
      • Department of Colon and Rectal Surgery
      • Contact: Jonathan Gruberg; Phone Number: 212-434-4350; Email: jgruberg@northwell.edu
      • Principal Investigator: Joseph Martz, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny Health Network
      • Principal Investigator: James McCormick, MD
      • Contact: Amie Pietropola; Phone Number: 412-330-4567; Email: Amie.Pietropola@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Cohort; 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; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Stoma-Free patients during the study follow up	Comparison of the number of stoma-free patients in the intervention group vs. the historical cohort at postoperative day 30, postoperative day 90, 6 months, and 12 months. (in %)	Time points 30 days, 90 days, 6 months and 12 months following the index surgery
Sensitivity and specificity of xBar outcome	Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).	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	Comparison of MCCI (Comorbidity Index) score based on National Surgical Quality Improvement Program scores, length of stay and readmission events at postoperative day 30 in the intervention group VS the historical cohort; Comparison of percentages of stoma-free patients in the intervention group vs. the historical cohort at POD30, POD90, 6 months, and 12 months.; Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).	At timepoints of 30, 90 ,180 and 365 days following the index surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tertiary Endpoint- Health Resource Utilization	Comparative assessment between study cohorts of overall and specific healthcare resource utilization related to index surgery and postoperative recovery at post operative days 30, 90 and 6 months, 12 months.	Post operative days 30, 90 and 6 months, 12 months
Exploratory Endpoint-Clinical Teams Usability Feedback	Use of questionnaires to collect feedback from clinical teams on system setup, intraoperative integration, postoperative monitoring, and decision-support utility.	As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.]

Collaborators and Investigators

• Sponsor: Exero Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CLP 04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No