Clinical trial NCT06168669: A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Official title: A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Anastomotic Leak
Lead sponsor: Exero Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 190
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible subjects will be assigned with the investigational device.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety
timeFrame: through study completion, an average of 1 year
measure: Safety - Severe leak rate - comparable to SOC.
timeFrame: through study completion, an average of 1 year
measure: Performance - successful xBar placement.
timeFrame: through study completion, an average of 1 year
measure: Performance - Sensitivity and Specificity of severe leak detection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
city: New York
country: United States
facility: Weill Cornell MC, NY
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: New York
country: United States
facility: Northwell Health, NY
state: New York
city: New York
country: United States
facility: Stony Brook University Hospital and Cancer Center
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Be'er Sheva
country: Israel
facility: Soroka MC
city: Petah tikva
country: Israel
facility: Rabin MC
city: Rehovot
country: Israel
facility: Kaplan MC
Study officials:
References: