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RECRUITING NA

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

NCT06168669 · View on ClinicalTrials.gov ↗

Study Summary

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

Interventions

  • DIAGNOSTIC_TEST xBar system

Study Locations (13)

New York

  • Weill Cornell MC, NY — New York
  • Mount Sinai Health System — New York
  • Northwell Health, NY — New York
  • Stony Brook University Hospital and Cancer Center — New York

Other

  • Soroka MC — Beersheba
  • Rabin MC — Petah Tikva
  • Kaplan MC — Rehovot

Florida

  • AdventHealth Orlando — Orlando
  • AdventHealth Tampa — Tampa

Kentucky

  • University of Louisville — Louisville

Michigan

  • Henry Ford Health — Detroit

Nebraska

  • Bryan Medical Center — Lincoln

Texas

  • HCA — Houston

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2023-03-11
Est. Completion 2025-12-01
Phase NA

Sponsor

Exero Medical

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06168669

The ClinicalTrials.gov registry entry for NCT06168669 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exero Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Colorectal Surgery appearing as the primary indexed condition, and to 1 intervention — of which xBar system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06168669 reports 13 study locations spanning 7 distinct geographic areas — top geographies include New York, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06168669 about?

NCT06168669 is a clinical study titled "A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection". Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

What is the current status of trial NCT06168669?

This trial is currently recruiting. It is a NA study. The enrollment target is 190 participants. The study started on 2023-03-11. Estimated completion is 2025-12-01.

What conditions does trial NCT06168669 study?

This clinical trial studies the following conditions: Colorectal Surgery, Anastomotic Leak. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06168669?

The interventions under investigation include: xBar system (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06168669?

This trial is sponsored by Exero Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06168669 being conducted?

This trial has 13 study locations across Florida, Kentucky, Michigan, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial