Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Обзор

Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.

Подробное описание

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.

Вмешательства

• Устройство xBar™ 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

Первичные конечные точки

• Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts [Срок оценки: 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) [Срок оценки: from the date of index surgery up to 365 days following the index surgery]

Вторичные конечные точки (3)

• Number of Stoma-Free patients during the study follow up [Срок оценки: Time points 30 days, 90 days, 6 months and 12 months following the index surgery]
• Sensitivity and specificity of xBar outcome [Срок оценки: 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 [Срок оценки: At timepoints of 30, 90 ,180 and 365 days following the index surgery]

Критерии участия

Критерии включения

Interventional Cohort

• Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
• Expected anastomosis within 10 cm from the anal verge
• Usage of drain during the surgery (to be confirmed during the surgery)
• Willing and able to comply with the study follow up and able and agree to provide informed consent.

Historical Cohort

• Adults aged ≥21 years at the time of surgery.
• Underwent a low anterior resection (LAR) for malignant colorectal disease.
• 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.

Критерии исключения

Interventional Cohort

• Subjects with benign disease
• Contraindication for surgery and/or general anesthesia.
• Known pregnancy or lactation.
• Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
• Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
• Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
• Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 6 центров

• University of Louisville Hospital — Louisville
• Johns Hopkins University — Baltimore
• Bryan Medical Center — Lincoln
• Weill Cornell Medicine Colon and Rectal Surgery — New York
• Department of Colon and Rectal Surgery — New York
• Allegheny Health Network — Pittsburgh

Идентификаторы

NCT: NCT07337590 · CLP 04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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