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COMPLETED NA

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

NCT01525849 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Conditions Studied

Interventions

  • DEVICE Balloon Sinus Dilation
  • PROCEDURE Functional Endoscopic Sinus Surgery

Study Locations (1)

Minnesota

  • Entellus Medical — Plymouth

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2011-12
Est. Completion 2014-05
Phase NA

Sponsor

Entellus Medical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01525849

The ClinicalTrials.gov registry entry for NCT01525849 describes a study currently listed as completed. 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 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Entellus Medical, which has 2 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 Chronic 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: NCT01525849 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. 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 NCT01525849 about?

NCT01525849 is a clinical study titled "Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up". The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

What is the current status of trial NCT01525849?

This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2011-12. Estimated completion is 2014-05.

What conditions does trial NCT01525849 study?

This clinical trial studies the following conditions: Chronic 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 NCT01525849?

The interventions under investigation include: Balloon Sinus Dilation (DEVICE), Functional Endoscopic Sinus Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01525849?

This trial is sponsored by Entellus Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01525849 being conducted?

This trial has 1 study location across Minnesota. 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