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In-office Repair of Chronic Tympanic Membrane Perforations

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Trial status: Suspended to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 30, 2026 to May 13, 2026
    v4
  2. Stopped Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Study drug is no longer available from Nobelpharma
    • Primary completion date: Sep 30, 2025 to Aug 30, 2026
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    • Eligibility criteria shortened, about 11 words
    v3
  3. Notable Primary endpoints: 1 to 2
    • Study description expanded, about 4 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the application of fibroblast growth factor 2 (FGF2) with normal saline for the healing of chronic tympanic membrane (TM) perforations. This is an extension of a prior study. The main question it aims to answer is: Will modifications to our prior surgical trial provide higher success rates in obtaining complete closure of chronic tympanic membrane perforations? Twenty participants will be randomized in a controlled study to FGF2 or saline in a 3:1 ratio and the total tympanic membrane closure compared.
Trial Details
NCT Number NCT06448039
Lead Sponsor D. Bradley Welling, MD, PhD
Collaborators: Nobelpharma
Conditions
(from sponsor)
Chronic Tympanic Membrane Perforation
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov