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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: Recruiting NA study of Colorectal Surgery and Anastomotic Leak, sponsored by Exero Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2023-03-11 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What NCT06168669 shows while recruiting
NCT06168669 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 306-participant average among 8 other Colorectal Surgery trials with a reported enrollment target (38% lower).
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 lists 13 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Colorectal Surgery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06168669's enrollment target sits among peer trials
190 5th of 8 higher than 4 of 8 other Colorectal Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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