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NCT06168669 · ClinicalTrials.gov registry record · NA

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

A NA study of Colorectal Surgery and Anastomotic Leak, sponsored by Exero Medical.

Recruiting
Registry status
NA
Development phase
190
Enrollment target
13
Study locations

NCT06168669 is a NA study of Colorectal Surgery and Anastomotic Leak that is actively recruiting participants, run by Exero Medical. The registered enrollment target is 190 participants, below the 306-participant average among 8 other Colorectal Surgery trials with a reported enrollment target (38% lower). The trial reports 13 study locations across 7 states.

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The verdict

NCT06168669, a NA study of Colorectal Surgery and Anastomotic Leak, is actively recruiting participants, sponsored by Exero Medical.

RECRUITING
Registry status
NA
Development phase
190 participants
Enrollment target
13
Study locations

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

2 total trials

What the Registry Record Tells You About NCT06168669

The ClinicalTrials.gov registry entry for NCT06168669 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 306-participant average among 8 other Colorectal Surgery trials with a reported enrollment target (38% lower). The listed sponsor is Exero Medical, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT06168669 reports 13 study locations spanning 7 distinct geographic areas - top geographies include New York, Other, Florida.

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.

What interventions are being tested in trial NCT06168669?

The interventions under investigation include: xBar system (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06168669?

This trial is sponsored by Exero Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

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