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NCT02087150 · ClinicalTrials.gov registry record · NA
Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 323
- Enrollment target
NCT02087150: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT02087150 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 323 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02087150, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 323 participants
- Enrollment target
Study Summary
The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.
Primary Outcome
The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance
Interventions
- DEVICE Acclarent Eustachian Tube Balloon Catheter (ETBC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2014-02-01 |
| Est. Completion | 2017-01-12 |
| Phase | NA |
What the finished NCT02087150 record still lists
NCT02087150 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Acclarent Eustachian Tube Balloon Catheter (ETBC) is the first listed.
NCT02087150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02087150 about?
NCT02087150 is a clinical study titled "Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter". The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.
What is the current status of trial NCT02087150?
This trial is currently completed. It is a NA study. The enrollment target is 323 participants. The study started on 2014-02-01. Estimated completion is 2017-01-12.
What interventions are being tested in trial NCT02087150?
The interventions under investigation include: Acclarent Eustachian Tube Balloon Catheter (ETBC) (DEVICE).
Who is sponsoring clinical trial NCT02087150?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02087150's enrollment target sits among peer trials
323 315th of 2000 higher than 1,686 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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