Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06041334 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

Study acronym: SPINLESS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jan 18, 2026 to Jul 18, 2027
    • Study completion date: Jan 18, 2027 to Jul 18, 2028
    • Site contact updated
    v4
  2. Primary completion date: Jan 18, 2025 to Jan 18, 2026v3 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Jan 18, 2026 to Jan 18, 2027
    • Secondary endpoints expanded, about 57 words
    • Site contact updated
    • Eligibility criteria expanded, about 5 words
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 1, 2023 to Jan 18, 2024
    • Primary completion date: Oct 1, 2024 to Jan 18, 2025
    • Study completion date: Oct 1, 2025 to Jan 18, 2026
    • Site details revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly. The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated. Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.
Trial Details
NCT Number NCT06041334
Lead Sponsor Rennes University Hospital
Collaborators: NeuroSphinx
Conditions
(from sponsor)		 Spina Bifida
Related terms Spinal Dysraphism
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov