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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anastomotic Leak; Colorectal Surgery
• Intervention / Treatment: Diagnostic test: xBar system

Detailed Description

Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.

xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.

Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Fishman; Phone Number: +972547545065; Email: ilana.fishman@exeromedical.com
• Study Contact Backup: Name: Gal Levi; Phone Number: +972543050574; Email: gal.levi@exeromedical.com

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Soroka MC
    • Contact: Ilya Pinsk, MD
  • Petah tikva, Israel
    • Rabin MC
    • Contact: Ian White, MD
  • Rehovot, Israel
    • Kaplan MC
    • Contact: Rafael Miller, MD
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
      • Contact: Patricia Sylla, MD
    • New York, New York, United States, 10021
      • Weill Cornell MC, NY
      • Contact: Dorna Jaffari, MD
      • Principal Investigator: Dorna Jaffari, MD
    • New York, New York, United States, 10075
      • Northwell Health, NY
      • Contact: Joseph Martz, MD
    • New York, New York, United States, 11794-8191
      • Stony Brook University Hospital and Cancer Center
      • Contact: Deborah Nagle, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
      • Contact: Eric Haas, MD; Phone Number: 713-790-0600; Email: ehaasmd@houstoncolon.com
      • Principal Investigator: Eric Haas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 22 years
2. Indication for sigmoid or rectal resection surgery.
3. Usage of drain during the surgery (to be confirmed during the surgery)
4. Willing and able to comply with the study follow up.
5. Able and agree to provide an informed consent.

Exclusion Criteria:

1. Contraindication for surgery and/or general anesthesia.
2. Pregnancy or lactation.
3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
7. Participation in another interventional study during the xBar system usage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Singel arm; All patients will be treated with the investigational device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period.	through study completion, an average of 1 year
Safety - Severe leak rate - comparable to SOC.	Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.	through study completion, an average of 1 year
Performance - successful xBar placement.	The device is working properly and records data in 90% of the cases or more.	through study completion, an average of 1 year
Performance - Sensitivity and Specificity of severe leak detection	Sensitivity and Specificity are non-inferior compared to Standard of care at POD 3	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Exero Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: CLP03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No