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NCT05915078
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
trial testing Iontophoresis and tube placement in Otitis Media With Effusion in 200 participants. Currently enrolling.
30 March 2025
Quick facts
| Lead sponsor | Smith & Nephew, Inc. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 15 June 2023 |
| Primary completion | 30 March 2025 |
| Estimated completion | 30 June 2027 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Iontophoresis and tube placement
Conditions studied
- Otitis Media With Effusion — all drugs for Otitis Media With Effusion →
- Acute Otitis Media — all drugs for Acute Otitis Media →
- Otitis Media — all drugs for Otitis Media →
Sponsor
Smith & Nephew, Inc. — full company profile →
Who can join
Adults 6 Months to 17, any sex, with Otitis Media With Effusion or Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation. The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05915078
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Otitis Media With Effusion
Currently open trials in the same condition.
- NCT07242001 — Laser Acupuncture for Otitis Media With Effusion in Children · NA · recruiting
- NCT05535634 — Sound Ear Check (SEC) in Hearing Diagnostics in Young Children · recruiting
Other Smith & Nephew, Inc. trials
Trials by the same sponsor.
- NCT07025304 — Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate · NA · recruiting
- NCT06916728 — A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Ca · enrolling by invitation
- NCT06831448 — Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin. · NA · completed
- NCT06700850 — Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin · NA · completed
- NCT06306716 — A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05915078 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
- Last refreshed: 23 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05915078.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing