Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01202578 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Tympanostomy Tube Delivery System
A Phase 2 study of Acute Otitis Media and Otitis Media With Effusion, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 4
- Study locations
NCT01202578: Completed Phase 2 study of Acute Otitis Media and Otitis Media With Effusion, sponsored by Integra LifeSciences Corporation.
NCT01202578 is a Phase 2 study of Acute Otitis Media and Otitis Media With Effusion that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 53 participants, below the 401-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01202578, a Phase 2 study of Acute Otitis Media and Otitis Media With Effusion, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Primary Outcome
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Conditions Studied
Interventions
- DEVICE tympanostomy tube
Study Locations (4)
Florida
- South Coast ENT - Port Saint Lucie
Kentucky
- Advanced ENT and Allergy - Louisville
Texas
- Ear Medical Group - San Antonio
Washington
- Evergreen Sinus Center - Kirkland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01202578 record still lists
NCT01202578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 401-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Acute Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which tympanostomy tube is the first listed.
NCT01202578 reports a single indexed study location in Florida, Kentucky, Texas.
Frequently Asked Questions
What is clinical trial NCT01202578 about?
NCT01202578 is a clinical study titled "Evaluation of the Tympanostomy Tube Delivery System". The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
What is the current status of trial NCT01202578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2010-09. Estimated completion is 2010-12.
What conditions does trial NCT01202578 study?
This clinical trial studies the following conditions: Acute Otitis Media, Otitis Media With Effusion.
What interventions are being tested in trial NCT01202578?
The interventions under investigation include: tympanostomy tube (DEVICE).
Who is sponsoring clinical trial NCT01202578?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202578 being conducted?
This trial has 4 study locations across Florida, Kentucky, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute 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 NCT01202578's enrollment target sits among peer trials
53 8th of 8 higher than 1 of 8 other Acute Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute 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
-
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
RECRUITING
-
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
RECRUITING · NA
-
RELAX: Reducing Length of Antibiotics for Children With Ear Infections
ACTIVE NOT RECRUITING · NA
-
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
ACTIVE NOT RECRUITING · NA
-
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
COMPLETED · NA
-
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
COMPLETED · Phase 3
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
- NCT04177004 · 53 participants · Phase 1
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
- NCT04199741 · 53 participants · Phase 1
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
- NCT04835129 · 53 participants · Phase 2
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
- NCT04913805 · 53 participants · Phase 2
Matching Perfusion and Metabolic Activity in HFpEF
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