Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
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.
University of Louisville Hospital
Louisville, Kentucky, United States
Weill Cornell Medicine Colon and Rectal Surgery
New York, New York, United States
Department of Colon and Rectal Surgery
New York, New York, United States
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
Number of Stoma-Free patients during the study follow up
Comparison of the number of stoma-free patients in the intervention group vs. the historical cohort at postoperative day 30, postoperative day 90, 6 months, and 12 months. (in %)
Time frame: Time points 30 days, 90 days, 6 months and 12 months following the index surgery
Sensitivity and specificity of xBar outcome
Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).
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
1. Comparison of MCCI (Comorbidity Index) score based on National Surgical Quality Improvement Program scores, length of stay and readmission events at postoperative day 30 in the intervention group VS the historical cohort 2. Comparison of percentages of stoma-free patients in the intervention group vs. the historical cohort at POD30, POD90, 6 months, and 12 months. 3. Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).
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Time frame: At timepoints of 30, 90 ,180 and 365 days following the index surgery