RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-11
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06168669

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 22 years
  2. 2. Indication for sigmoid or rectal resection surgery.
  3. 3. Usage of drain during the surgery (to be confirmed during the surgery)
  4. 4. Willing and able to comply with the study follow up.
  5. 5. Able and agree to provide an informed consent.
  1. 1. Contraindication for surgery and/or general anesthesia.
  2. 2. Pregnancy or lactation.
  3. 3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
  4. 4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
  5. 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. 6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
  7. 7. Participation in another interventional study during the xBar system usage.

Contacts and Locations

Study Contact

Ilana Fishman
CONTACT
+972547545065
ilana.fishman@exeromedical.com
Gal Levi
CONTACT
+972543050574
gal.levi@exeromedical.com

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Bryan Medical Center
Lincoln, Nebraska, 68506
United States
Weill Cornell MC, NY
New York, New York, 10021
United States
Mount Sinai Health System
New York, New York, 10029
United States
Northwell Health, NY
New York, New York, 10075
United States
Stony Brook University Hospital and Cancer Center
New York, New York, 11794-8191
United States
Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-03-11
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-03-11
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Surgery
  • Anastomotic Leak