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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Exero Medical Ltd.
Study ID
NCT06168669
Status
Recruiting
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Conditions

  • Anastomotic Leak
  • Colorectal Surgery

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • xBar system — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date
Mar 11, 2023
Status verified
Sep 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
190 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Singel arm
    All patients will be treated with the investigational device.

Primary Outcome Measure

Safety [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
AdventHealth OrlandoOrlandoFlorida328803
Mark Soliman, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth TampaTampaFlorida33613
Daniel Robledo
[email protected]
8136108110
Ahmed Allawi, MD (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40202
Sandra Kavalukas, MD
Henry Ford HealthDetroitMichigan48202
Craig Reickert, MD
Bryan Medical CenterLincolnNebraska68506
Micheal Jobst, MD
Mount Sinai Health SystemNew YorkNew York10029
Patricia Sylla, MD
Northwell Health, NYNew YorkNew York10075
Joseph Martz, MD
Stony Brook University Hospital and Cancer CenterNew YorkNew York11794-8191
Deborah Nagle, MD
Weill Cornell MC, NYNew YorkNew York10021
Dorna Jaffari, MD
Dorna Jaffari, MD (PRINCIPAL_INVESTIGATOR)
HCAHoustonTexas77030
Eric Haas, MD
[email protected]
713-790-0600
Eric Haas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
AdventHealth Orlando· Orlando, FLAdventHealth Tampa· Tampa, FLUniversity of Louisville· Louisville, KYHenry Ford Health· Detroit, MIBryan Medical Center· Lincoln, NEMount Sinai Health System· New York, NY

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