NCT07337590 · Exero Medical Ltd.
Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
(ASSURE)
What this study is about
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
View original scientific description
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 1\. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
Where
- Louisville, Kentucky
- Baltimore, Maryland
- Lincoln, Nebraska
- New York, New York
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations