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Vaginal Orthosis Use After Vaginal Reconstructive Surgery

Study acronym: NOVa
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Study completion date changed from estimate of Sep 1, 2026 to Sep 25, 2026 · Eligibility criteria expanded, about 13 words Show 2 more changesShow less
    • Study completion date changed from estimate of Sep 1, 2026 to Sep 25, 2026
    • Eligibility criteria expanded, about 13 words
  2. Primary completion date changed from estimate of Jun 2026 to Jul 1, 2026 Completion date: Jul 2026 to Sep 1, 2026 · Collaborators expanded, about 2 wordsv7 Show 2 more changesShow less
    • Completion date: Jul 2026 to Sep 1, 2026
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Primary completion date: Mar 2026 to Jun 2026 · Completion date: Mar 2026 to Jul 2026v6 Show 2 more changesShow less
    • Primary completion date: Mar 2026 to Jun 2026
    • Completion date: Mar 2026 to Jul 2026
  4. Primary completion date: Jun 2025 to Mar 2026 Completion date: Sep 2025 to Mar 2026v5 Show 1 more changeShow less
    • Completion date: Sep 2025 to Mar 2026
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Jan 2024 to Jan 29, 2024v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Jan 29, 2024
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 2023 to Jan 2024v3
  2. Start date: Sep 2023 to Nov 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
Trial Details
NCT Number NCT05812859
Lead Sponsor University of Alabama at Birmingham
Collaborators: Cosm Medical
Conditions Pelvic Organ Prolapse
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov