Actively Recruiting
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Led by Exero Medical Ltd. · Updated on 2025-09-30
190
Participants Needed
13
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Scheduled for sigmoid or rectal resection surgery
- Usage of a drain during surgery (confirmed during surgery)
- Willing and able to comply with study follow-up
- Able and willing to provide informed consent
You will not qualify if you...
- Contraindication for surgery and/or general anesthesia
- Pregnancy or lactation
- Planned or unplanned fecal diversion during surgery (confirmed during surgery)
- Known implanted electronic device in chest or abdomen (e.g., pacemaker, defibrillator)
- Major medical or psychiatric illness affecting health or ability to adhere to follow-up
- Known allergy to materials in the xBar system (silicone, rubber, stainless steel)
- Participation in another interventional study during xBar system usage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
AdventHealth Orlando
Orlando, Florida, United States, 328803
Actively Recruiting
2
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
3
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
Henry Ford Health
Detroit, Michigan, United States, 48202
Not Yet Recruiting
5
Bryan Medical Center
Lincoln, Nebraska, United States, 68506
Actively Recruiting
6
Weill Cornell MC, NY
New York, New York, United States, 10021
Actively Recruiting
7
Mount Sinai Health System
New York, New York, United States, 10029
Actively Recruiting
8
Northwell Health, NY
New York, New York, United States, 10075
Actively Recruiting
9
Stony Brook University Hospital and Cancer Center
New York, New York, United States, 11794-8191
Actively Recruiting
10
HCA
Houston, Texas, United States, 77030
Actively Recruiting
11
Soroka MC
Beersheba, Israel
Actively Recruiting
12
Rabin MC
Petah Tikva, Israel
Actively Recruiting
13
Kaplan MC
Rehovot, Israel
Actively Recruiting
Research Team
I
Ilana Fishman
CONTACT
E
Erez Shor, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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