Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Exero Medical Ltd.
Study ID
NCT07337590
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • xBar™ System — DEVICE
    Device: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols.

Study Details

Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.

Key Dates

Start date
Mar 10, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Interventional Cohort
    The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal.
  • No Intervention: Historical Control Cohort
    A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.

Primary Outcome Measure

Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts [ Time Frame: At the time points of 30 and 90 days following index surgery ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Louisville HospitalLouisvilleKentucky40202
Kiel Carson Butterfield
[email protected]
Sandra Kavalukas, MD (PRINCIPAL_INVESTIGATOR)
Department of Colon and Rectal SurgeryNew YorkNew York10075
Jonathan Gruberg
[email protected]
212-434-4350
Joseph Martz, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine Colon and Rectal SurgeryNew YorkNew York10021
KM Muktasid
[email protected]
646-962-2789
Mehraneh D Jafari, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15212
Rachel Reading, MSHCPM
[email protected]
412-359-8664
James McCormick, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Louisville Hospital· Louisville, KYDepartment of Colon and Rectal Surgery· New York, NYWeill Cornell Medicine Colon and Rectal Surgery· New York, NYAllegheny Health Network· Pittsburgh, PA

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