Colorectal Cancer
Conditions
Brief 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.
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.
Sponsors
Exero Medical Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study will include two cohorts: * Interventional Cohort: Approximately 80 eligible subjects with colorectal cancer undergoing elective low anterior resection with anastomosis, without concomitant diversion, who meet all study inclusion criteria and none of the exclusion criteria. * Historical Control Cohort: A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Interventional Cohort 1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer 2. Expected anastomosis within 10 cm from the anal verge 3. Usage of drain during the surgery (to be confirmed during the surgery) 4. Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort 1. Adults aged ≥21 years at the time of surgery. 2. Underwent a low anterior resection (LAR) for malignant colorectal disease. 3. Documented colorectal anastomosis located \<10cm from the anal verge, or documented tumor \<10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.
Exclusion criteria
Interventional Cohort 1. Subjects with benign disease 2. Contraindication for surgery and/or general anesthesia. 3. Known pregnancy or lactation. 4. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively) 5. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 6. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 7. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. 8. Participation in another interventional study during the xBar system usage. Historical Cohort 1\. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts | At the time points of 30 and 90 days following index surgery | 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. |
| 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) | from the date of index surgery up to 365 days following the 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Stoma-Free patients during the study follow up | Time points 30 days, 90 days, 6 months and 12 months following the index surgery | 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 %) |
| Sensitivity and specificity of xBar outcome | As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days. | Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value). |
| 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 | At timepoints of 30, 90 ,180 and 365 days following the index surgery | 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). |
Countries
United States
Contacts
CONTACTIlana Fishman
CONTACTRuth Stone
Outcome results
None listed