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

Recruiting

Who can join

Ages 21 and older · All sexes

Full 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).

About the study

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

What is being tested

Sponsor: Exero Medical Ltd. · Participants: 80 · Started: Mar 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07337590

Locations in the U.S.

KentuckyUniversity of Louisville Hospital, Louisville
MarylandJohns Hopkins University, Baltimore
NebraskaBryan Medical Center, Lincoln
New YorkDepartment of Colon and Rectal Surgery, New York (Not yet recruiting)
Weill Cornell Medicine Colon and Rectal Surgery, New York
PennsylvaniaAllegheny Health Network, Pittsburgh

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.