Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01496287 · ClinicalTrials.gov registry record · NA
Tympanostomy Tube Placement in Children in the Office (Inova Study)
A NA study of Otitis Media, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01496287: Completed NA study of Otitis Media, sponsored by Integra LifeSciences Corporation.
NCT01496287 is a NA study of Otitis Media that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 70 participants, below the 4,339-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496287, a NA study of Otitis Media, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
Primary Outcome
Adverse events which are procedural, serious, and device-related.
Conditions Studied
Interventions
- DEVICE Tube Delivery System (TDS)
Study Locations (1)
Florida
- South Coast Ear, Nose & Throat - Port Saint Lucie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT01496287 record still lists
NCT01496287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 4,339-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Tube Delivery System (TDS) is the first listed.
NCT01496287 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01496287 about?
NCT01496287 is a clinical study titled "Tympanostomy Tube Placement in Children in the Office (Inova Study)". The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
What is the current status of trial NCT01496287?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2011-12. Estimated completion is 2012-04.
What conditions does trial NCT01496287 study?
This clinical trial studies the following conditions: Otitis Media.
What interventions are being tested in trial NCT01496287?
The interventions under investigation include: Tube Delivery System (TDS) (DEVICE).
Who is sponsoring clinical trial NCT01496287?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01496287 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Otitis Media
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01496287's enrollment target sits among peer trials
70 11th of 14 higher than 4 of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media 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
-
In-Office Clinical Study of the Solo+ TTD
RECRUITING · NA
-
Coherent Optical Detection of Middle Ear Disease
RECRUITING · NA
-
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
ACTIVE NOT RECRUITING · NA
-
The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
COMPLETED · NA
-
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
COMPLETED · NA
-
Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia