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

Not Applicable

Recruiting

• Conditions: Anastomotic Leak; Colorectal Surgery
• Interventions: Diagnostic Test: xBar system

• Registration Number: NCT06168669
• Lead Sponsor: Exero Medical Ltd.

Brief 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.

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 Timeline

• Study Start: 2023-03-11
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Singel arm	xBar system	All patients will be treated with the investigational device.

Primary Outcome Measures

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

Trial Locations

Locations (12)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Bryan Medical Center; 🇺🇸 Lincoln, Nebraska, United States

Weill Cornell MC, NY; 🇺🇸 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

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Mount Sinai Health System; 🇺🇸 New York, New York, United States

Soroka MC; 🇮🇱 Be'er Sheva, Israel

Rabin MC; 🇮🇱 Petah tikva, Israel

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Kaplan MC; 🇮🇱 Rehovot, Israel