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IMED-MYVEONCT07164053

Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.

StatusWithdrawn
PhaseNot specified
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Withdrawn before enrolling Sponsor's reason: sufficient existing clinical evidence Show 5 more changesShow less
    • Enrollment target: estimated 32 to confirmed 0
    • Start date: Dec 25, 2025 to Oct 2026
    • Primary and study completion dates moved earlier to Oct 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Start date: Oct 1, 2025 to Dec 25, 2025v3
  3. Site contacts updated at 1 of 2 sitesv2
  4. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

White Light and Fluorescence image quality
Timeframe: Periprocedural

Secondary (1)

The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications.

Arms and interventions

Devices: MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su