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NCT Number: NCT07337590

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

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Hospital, Louisville, Kentucky, United States

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About this study

The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.

The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

xBar™ System

Device

Device: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols.

Primary outcomes

  1. Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts

    Time frame: At the time points of 30 and 90 days following index surgery

    Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.

  2. Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)

    Time frame: from the date of index surgery up to 365 days following the index surgery

    Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)

Secondary outcomes

  1. Number of Stoma-Free patients during the study follow up

    Time frame: Time points 30 days, 90 days, 6 months and 12 months following the index surgery

    Comparison of the number of stoma-free patients in the intervention group vs. the historical cohort at postoperative day 30, postoperative day 90, 6 months, and 12 months. (in %)

  2. Sensitivity and specificity of xBar outcome

    Time frame: As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.

    Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).

  3. 1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome

    Time frame: At timepoints of 30, 90 ,180 and 365 days following the index surgery

    • Comparison of MCCI (Comorbidity Index) score based on National Surgical Quality Improvement Program scores, length of stay and readmission events at postoperative day 30 in the intervention group VS the historical cohort
    • Comparison of percentages of stoma-free patients in the intervention group vs. the historical cohort at POD30, POD90, 6 months, and 12 months.
    • Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).

Other outcomes

  1. Tertiary Endpoint- Health Resource Utilization

    Time frame: Post operative days 30, 90 and 6 months, 12 months

    Comparative assessment between study cohorts of overall and specific healthcare resource utilization related to index surgery and postoperative recovery at post operative days 30, 90 and 6 months, 12 months.

  2. Exploratory Endpoint-Clinical Teams Usability Feedback

    Time frame: As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.]

    Use of questionnaires to collect feedback from clinical teams on system setup, intraoperative integration, postoperative monitoring, and decision-support utility.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilana Fishman

CONTACT

[email protected]

+972547545065

Ruth Stone

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Exero Medical Ltd.

Industry

Registry information

Acronym: ASSURE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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