A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

September 16, 2026 updated by: Exero Medical Ltd.

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.

The clinical team is blinded to the leak detection of the xBar system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.

xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.

Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beersheba, Israel
        • Soroka MC
      • Petah Tikva, Israel
        • Rabin MC
      • Rehovot, Israel
        • Kaplan MC
  • United States
    • Florida
      • Orlando, Florida, United States, 328803
        • AdventHealth Orlando
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Health System
      • New York, New York, United States, 10021
        • Weill Cornell MC, NY
      • New York, New York, United States, 10075
        • Northwell Health, NY
      • New York, New York, United States, 11794-8191
        • Stony Brook University Hospital and Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • HCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 22 years
  2. Indication for sigmoid or rectal resection surgery.
  3. Usage of drain during the surgery (to be confirmed during the surgery)
  4. Willing and able to comply with the study follow up.
  5. Able and agree to provide an informed consent.

Exclusion Criteria:

  1. Contraindication for surgery and/or general anesthesia.
  2. Pregnancy or lactation.
  3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
  4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
  5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
  6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
  7. Participation in another interventional study during the xBar system usage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Singel arm
All patients will be treated with the investigational device.
Diagnostic test: xBar system
xBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: through study completion, an average of 1 year
Incidence of Unanticipated Serious Adverse Events Related to the xBar System or xBar Procedure
through study completion, an average of 1 year
Safety - Severe leak rate - comparable to SOC.
Time Frame: through study completion, an average of 1 year
Incidence of Severe Anastomotic Leak. Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.
through study completion, an average of 1 year
Performance - xBar Technical Success Rate
Time Frame: through study completion, an average of 1 year
xBar Technical Success Rate
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: From the xBar placement up to POD3
Sensitivity of xBar for Detection of Severe Anastomotic Leak assuming is non-inferior compared to Standard of care at POD 3
From the xBar placement up to POD3
Specificity
Time Frame: from the xBar placement up to post operative day 3
Specificity of xBar for Detection of Severe Anastomotic Leak assuming is non -inferior to standard of care detection
from the xBar placement up to post operative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exero Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2023

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP03

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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