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NCT01525849 · ClinicalTrials.gov registry record · NA

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

A NA study of Chronic Sinusitis, sponsored by Entellus Medical.

Completed
Registry status
NA
Development phase
151
Enrollment target
1
Study location

NCT01525849 is a NA study of Chronic Sinusitis that has completed, run by Entellus Medical. The registered enrollment target is 151 participants, below the 179-participant average among 9 other Chronic Sinusitis trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01525849, a NA study of Chronic Sinusitis, has completed, sponsored by Entellus Medical.

COMPLETED
Registry status
NA
Development phase
151 participants
Enrollment target
1
Study location

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

11 total trials

What the Registry Record Tells You About NCT01525849

The ClinicalTrials.gov registry entry for NCT01525849 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 9 other Chronic Sinusitis trials with a reported enrollment target (16% lower). The listed sponsor is Entellus Medical, which has 11 total studies on file at ClinicalTrials.gov.

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.

NCT01525849 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

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.

What interventions are being tested in trial NCT01525849?

The interventions under investigation include: Balloon Sinus Dilation (DEVICE), Functional Endoscopic Sinus Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01525849?

This trial is sponsored by Entellus Medical, which has 11 total clinical trials registered on ClinicalTrials.gov.

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.

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

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