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SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis

Study acronym: RESOLVE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2025 to Sep 2025
    • Study sites: 0 to 1
    v3
  2. Primary endpoints: 2 to 1
    • Secondary endpoints shortened, about 5 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the study is to assess the efficacy, safety and the clinical benefit of the SiREX stent for the treatment of disabling pulsatile tinnitus due to stenosis of lateral sinus. The study will enrol patients suffering from pulsatile tinnitus related to a lateral sinus stenosis lasting more than three months, and who want to be treated with lateral sinus stenting
Trial Details
NCT Number NCT06726928
Lead Sponsor Acandis GmbH
Conditions
(from sponsor)		 Treatment of Symptomatic Lateral Sinus Stenosis, Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis
Related terms Tinnitus
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov