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COMPLETED

Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

NCT01685229 · View on ClinicalTrials.gov ↗

Study Summary

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

Conditions Studied

Interventions

  • DEVICE Balloon sinus dilation
  • DRUG Medical Management

Study Locations (20)

Georgia

  • — Atlanta
  • — Savannah
  • — Vidalia

Texas

  • — Frisco
  • — McKinney
  • — Plano

Virginia

  • — Charlottesville
  • — Norfolk
  • — Richmond

Florida

  • — Miami
  • — Tampa

Illinois

  • — Chicago
  • — Rockford

Wisconsin

  • — Beaver Dam
  • — Wauwatosa

Colorado

  • — Denver

Indiana

  • — South Bend

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2012-09-01
Est. Completion 2015-08-01

Sponsor

Integra LifeSciences Corporation

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01685229

The ClinicalTrials.gov registry entry for NCT01685229 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sinusitis appearing as the primary indexed condition, and to 2 interventions — of which Balloon sinus dilation 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: NCT01685229 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Georgia, Texas, Virginia. 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 NCT01685229 about?

NCT01685229 is a clinical study titled "Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis". This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

What is the current status of trial NCT01685229?

This trial is currently completed. The enrollment target is 198 participants. The study started on 2012-09-01. Estimated completion is 2015-08-01.

What conditions does trial NCT01685229 study?

This clinical trial studies the following conditions: Sinusitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01685229?

The interventions under investigation include: Balloon sinus dilation (DEVICE), Medical Management (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01685229?

This trial is sponsored by Integra LifeSciences Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01685229 being conducted?

This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Indiana. 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