Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
Summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
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.
Arms & interventions
- DevicexBar™ 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.
Outcome measures
Primary
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.
Time frame: At the time points of 30 and 90 days following index surgery
Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)
Time frame: from the date of index surgery up to 365 days following the index surgery
Secondary
Number of Stoma-Free patients during the study follow up
Time frame: Time points 30 days, 90 days, 6 months and 12 months following the index surgery
Sensitivity and specificity of xBar outcome
Time frame: As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.
1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome
Time frame: At timepoints of 30, 90 ,180 and 365 days following the index surgery
Eligibility criteria
Study locations (6)
University of Louisville Hospital
Louisville, Kentucky, 40202
Johns Hopkins University
Baltimore, Maryland, 21287
Bryan Medical Center
Lincoln, Nebraska, 68506
Weill Cornell Medicine Colon and Rectal Surgery
New York, New York, 10021
Department of Colon and Rectal Surgery
New York, New York, 10075
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212