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

Purpose

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

Condition

  • Colorectal Cancer

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Interventional Cohort 1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer 2. Expected anastomosis within 10 cm from the anal verge 3. Usage of drain during the surgery (to be confirmed during the surgery) 4. Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort 1. Adults aged ≥21 years at the time of surgery. 2. Underwent a low anterior resection (LAR) for malignant colorectal disease. 3. Documented colorectal anastomosis located <10cm from the anal verge, or documented tumor <10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.

Exclusion Criteria

Interventional Cohort 1. Subjects with benign disease 2. Contraindication for surgery and/or general anesthesia. 3. Known pregnancy or lactation. 4. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively) 5. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 6. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 7. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. 8. Participation in another interventional study during the xBar system usage. Historical Cohort 1. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study will include two cohorts: - Interventional Cohort: Approximately 80 eligible subjects with colorectal cancer undergoing elective low anterior resection with anastomosis, without concomitant diversion, who meet all study inclusion criteria and none of the exclusion criteria. - 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 Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: xBar™ System
    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.
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.

Recruiting Locations

University of Louisville Hospital
Louisville, Kentucky 40202
Contact:
Kiel Carson Butterfield
kiel.carsonbutterfield@louisville.edu

Johns Hopkins University
Baltimore, Maryland 21287
Contact:
Jodie Frost
jfrost17@jhmi.edu

Bryan Medical Center
Lincoln, Nebraska 68506
Contact:
Kristin Williams
kristin.williams@bryanhealth.org

Weill Cornell Medicine Colon and Rectal Surgery
New York, New York 10021
Contact:
KM Muktasid
646-962-2789
kmm4010@med.cornell.edu

Allegheny Health Network
Pittsburgh, Pennsylvania 15212
Contact:
Amie Pietropola
412-330-4567
Amie.Pietropola@ahn.org

More Details

Status
Recruiting
Sponsor
Exero Medical Ltd.

Study Contact

Ilana Fishman
+972547545065
ilana.fishman@exeromedical.com

Detailed Description

The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group. The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.