NCT06168669

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

December 4, 2023

Last Update Submit

September 29, 2025

Conditions

Colorectal SurgeryAnastomotic Leak

Outcome Measures

Primary Outcomes (4)

  • Safety

    Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period.

    through study completion, an average of 1 year

  • Safety - Severe leak rate - comparable to SOC.

    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 - successful xBar placement.

    The device is working properly and records data in 90% of the cases or more.

    through study completion, an average of 1 year

  • Performance - Sensitivity and Specificity of severe leak detection

    Sensitivity and Specificity are non-inferior compared to Standard of care at POD 3

    through study completion, an average of 1 year

Study Arms (1)

Singel arm

OTHER

All patients will be treated with the investigational device.

Diagnostic Test: xBar system

Interventions

xBar systemDIAGNOSTIC_TEST

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.

Singel arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication for surgery and/or general anesthesia.
  • Pregnancy or lactation.
  • Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
  • Known electronic device 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

AdventHealth Orlando

Orlando, Florida, 328803, United States

RECRUITING

AdventHealth Tampa

Tampa, Florida, 33613, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

RECRUITING

Weill Cornell MC, NY

New York, New York, 10021, United States

RECRUITING

Mount Sinai Health System

New York, New York, 10029, United States

RECRUITING

Northwell Health, NY

New York, New York, 10075, United States

RECRUITING

Stony Brook University Hospital and Cancer Center

New York, New York, 11794-8191, United States

RECRUITING

HCA

Houston, Texas, 77030, United States

RECRUITING

Soroka MC

Beersheba, Israel

RECRUITING

Rabin MC

Petah Tikva, Israel

RECRUITING

Kaplan MC

Rehovot, Israel

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ilana Fishman

CONTACT

+972547545065ilana.fishman@exeromedical.com

Erez Shor, PhD

CONTACT

+972 54 2600911erez.shor@exeromedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigators, clinical teams and subjects will be blinded to the outcomes provided by xBar system. Post operative monitoring will be as per SOC.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All eligible subjects will be assigned with the investigational device.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 13, 2023

Study Start

March 11, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(3)US(10)