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

Description

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.

Conditions

Colorectal Surgery, Anastomotic Leak

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Colorectal Surgery
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Lincoln

Bryan Medical Center, Lincoln, Nebraska, United States, 68506

New York

Weill Cornell MC, NY, New York, New York, United States, 10021

New York

Mount Sinai Health System, New York, New York, United States, 10029

New York

Northwell Health, NY, New York, New York, United States, 10075

New York

Stony Brook University Hospital and Cancer Center, New York, New York, United States, 11794-8191

Houston

Houston Methodist, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exero Medical Ltd.,

Study Record Dates

2025-12-01