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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Cohort | Experimental | The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal. |
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| Historical Control Cohort | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xBarâ„¢ System | Device | Device: The xBarâ„¢ 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 xBarâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | from the date of index surgery up to 365 days following the index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 points 30 days, 90 days, 6 months and 12 months following the index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary Endpoint- Health Resource Utilization | Comparative assessment between study cohorts of overall and specific healthcare resource utilization related to index surgery and postoperative recovery at post operative days 30, 90 and 6 months, 12 months. | Post operative days 30, 90 and 6 months, 12 months |
| Exploratory Endpoint-Clinical Teams Usability Feedback |
Inclusion Criteria:
Interventional Cohort
Historical Cohort
Exclusion Criteria:
Interventional Cohort
1. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilana Fishman | Contact | +972547545065 | ilana.fishman@exeromedical.com | |
| Ruth Stone | Contact | ruth.stone@exeromedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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The study will include two cohorts:
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| Sensitivity and specificity of xBar outcome |
Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value). |
| 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 |
| At timepoints of 30, 90 ,180 and 365 days following the index surgery |
Use of questionnaires to collect feedback from clinical teams on system setup, intraoperative integration, postoperative monitoring, and decision-support utility. |
| As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.] |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Bryan Medical Center | Recruiting | Lincoln | Nebraska | 68506 | United States |
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| Weill Cornell Medicine Colon and Rectal Surgery | Recruiting | New York | New York | 10021 | United States |
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| Department of Colon and Rectal Surgery | Not yet recruiting | New York | New York | 10075 | United States |
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| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |