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NCT05826743 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
A NA study of Colorectal Cancer and Colorectal Surgery, sponsored by JSR Medical Co..
- Recruiting
- Registry status
- NA
- Development phase
- 256
- Enrollment target
- 3
- Study locations
NCT05826743: Recruiting NA study of Colorectal Cancer and Colorectal Surgery, sponsored by JSR Medical Co..
NCT05826743 is a NA study of Colorectal Cancer and Colorectal Surgery that is actively recruiting participants, run by JSR Medical Co.. The registered enrollment target is 256 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05826743, a NA study of Colorectal Cancer and Colorectal Surgery, is actively recruiting participants, sponsored by JSR Medical Co..
- RECRUITING
- Registry status
- NA
- Development phase
- 256 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
Primary Outcome
Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy
Conditions Studied
Interventions
- DEVICE COLO BT™
- OTHER Stoma Creation
Study Locations (3)
New York
- Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo - Buffalo
Pennsylvania
- PennState Health - Milton S. Hershey Medical Center - Hershey
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2027-03-15 |
| Phase | NA |
What NCT05826743 shows while recruiting
NCT05826743 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (83% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which COLO BT™ is the first listed.
NCT05826743 reports a single indexed study location in New York, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05826743 about?
NCT05826743 is a clinical study titled "Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy". The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
What is the current status of trial NCT05826743?
This trial is currently recruiting. It is a NA study. The enrollment target is 256 participants. The study started on 2023-12-04. Estimated completion is 2027-03-15.
What conditions does trial NCT05826743 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colorectal Surgery, Ileostomy - Stoma, Rectal/Anal, Anastomotic Leakage.
What interventions are being tested in trial NCT05826743?
The interventions under investigation include: COLO BT™ (DEVICE), Stoma Creation (OTHER).
Who is sponsoring clinical trial NCT05826743?
This trial is sponsored by JSR Medical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05826743 being conducted?
This trial has 3 study locations across New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05826743's enrollment target sits among peer trials
256 127th of 381 higher than 255 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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