Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy

NCT05826743 · View on ClinicalTrials.gov ↗

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

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05826743

The ClinicalTrials.gov registry entry for NCT05826743 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 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JSR Medical Co., 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 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which COLO BT™ 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: NCT05826743 reports 3 study locations spanning 3 distinct geographic areas — top geographies include New York, Pennsylvania, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05826743?

The interventions under investigation include: COLO BT™ (DEVICE), Stoma Creation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05826743?

This trial is sponsored by JSR Medical Co., 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 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.

Related

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