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

NARecruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

March 11, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Colorectal SurgeryAnastomotic Leak
Interventions
DIAGNOSTIC_TEST

xBar system

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.

Trial Locations (13)

10021

RECRUITING

Weill Cornell MC, NY, New York

10029

RECRUITING

Mount Sinai Health System, New York

10075

RECRUITING

Northwell Health, NY, New York

33613

RECRUITING

AdventHealth Tampa, Tampa

40202

RECRUITING

University of Louisville, Louisville

48202

NOT_YET_RECRUITING

Henry Ford Health, Detroit

68506

RECRUITING

Bryan Medical Center, Lincoln

77030

RECRUITING

HCA, Houston

328803

RECRUITING

AdventHealth Orlando, Orlando

11794-8191

RECRUITING

Stony Brook University Hospital and Cancer Center, New York

Unknown

RECRUITING

Soroka MC, Beersheba

RECRUITING

Rabin MC, Petah Tikva

RECRUITING

Kaplan MC, Rehovot

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Exero Medical Ltd.

INDUSTRY