Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar (ASSURE)

Exero Medical

Status: Not yet enrolling

Conditions: Colorectal Cancer

Treatments: Device: xBar™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07337590

CLP 04

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Interventional Cohort

Experimental group

Description:

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.

Treatment:

Device: xBar™ System

Historical Control Cohort

No Intervention group

Description:

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.