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Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Jul 1, 2025
    • Study completion date changed from estimate of Oct 2026 to Aug 31, 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
    • Publications: details revised at 5 of 5 entries
  2. Secondary endpoints: 7 to 9v8
  3. Eligibility criteria expanded, about 35 words
    • Secondary endpoints expanded, about 36 words
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Jun 19, 2024
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 2024 to Jun 2024v4
  2. Start date: Dec 2023 to Apr 2024v3
  3. Start date: Sep 2023 to Dec 2023v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group. The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.
Trial Details
NCT Number NCT06059599
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)		 Spine Disease, Urologic Diseases
Related terms Spinal Diseases, Urologic Diseases
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov