NCT07337590 Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
| NCT ID | NCT07337590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exero Medical Ltd. |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-03-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07337590 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07337590 currently recruiting?
Yes, NCT07337590 is actively recruiting participants. Contact the research team at ilana.fishman@exeromedical.com for enrollment information.
Where is the NCT07337590 trial being conducted?
This trial is being conducted at Louisville, United States, Baltimore, United States, Lincoln, United States, New York, United States and 2 additional locations.
Who is sponsoring the NCT07337590 clinical trial?
NCT07337590 is sponsored by Exero Medical Ltd.. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.