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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06168669
• Other study ID #: CLP03
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Exero Medical Ltd.
• Contact: Ilana Fishman
• Phone: +972547545065
• Email: ilana.fishman[@]exeromedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Surgery

Intervention

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.

Locations

Country	Name	City	State
Israel	Soroka MC	Be'er Sheva
Israel	Rabin MC	Petah tikva
Israel	Kaplan MC	Rehovot
United States	Johns Hopkins University	Baltimore	Maryland
United States	Henry Ford Health	Detroit	Michigan
United States	Houston Methodist	Houston	Texas
United States	Mount Sinai Health System	New York	New York
United States	Northwell Health, NY	New York	New York
United States	Stony Brook University Hospital and Cancer Center	New York	New York
United States	Weill Cornell MC, NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Exero Medical Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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