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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 3 states.

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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)

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

FieldValue
Enrollment Target 256 participants
Start Date 2023-12-04
Est. Completion 2027-03-15
Phase NA

Sponsor

JSR Medical Co.

1 total trials

What the Registry Record Tells You About NCT05826743

The ClinicalTrials.gov registry entry for NCT05826743 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (83% lower). The listed sponsor is JSR Medical Co., which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.