Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07337590

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

Led by Exero Medical Ltd. · Updated on 2026-04-15

80

Participants Needed

4

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 21 years or older scheduled for elective low anterior resection surgery for colorectal cancer
  • Expected anastomosis located within 10 cm from the anal verge
  • Use of a surgical drain during the surgery
  • Willing and able to comply with study follow-up and provide informed consent
  • Historical cohort includes adults 21 years or older who underwent low anterior resection for malignant colorectal disease
  • Documented colorectal anastomosis or tumor less than 10 cm from the anal verge with complete hospitalization and 12-month follow-up records or up to stoma take down procedure
Not Eligible

You will not qualify if you...

  • Subjects with benign colorectal disease
  • Contraindications for surgery or general anesthesia
  • Known pregnancy or lactation
  • Subjects receiving prophylactic stoma formation during index surgery
  • Presence of implanted electronic devices in chest or abdomen (e.g., pacemaker, defibrillator)
  • Major medical or psychiatric illness affecting health or study follow-up adherence
  • Known allergies to materials in the xBar system (silicone, rubber, stainless steel)
  • Participation in another interventional study during xBar usage
  • Historical cohort excludes LAR performed for benign or non-oncologic conditions such as diverticulitis, inflammatory bowel disease, non-malignant strictures, or fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University of Louisville Hospital

Louisville, Kentucky, United States, 40202

Not Yet Recruiting

2

Weill Cornell Medicine Colon and Rectal Surgery

New York, New York, United States, 10021

Actively Recruiting

3

Department of Colon and Rectal Surgery

New York, New York, United States, 10075

Not Yet Recruiting

4

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

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Research Team

I

Ilana Fishman

CONTACT

R

Ruth Stone

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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