Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
Recruiting · NCT07337590 · Interventional (participants receive a specific treatment) · Lead sponsor: Exero Medical Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
xBar™ System
What this trial is about
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
- \. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
Where it is running
6 locations listed across 5 US states.
- University of Louisville Hospital - Louisville, Kentucky, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Bryan Medical Center - Lincoln, Nebraska, 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
- Allegheny Health Network - Pittsburgh, Pennsylvania, United States