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Validation of Nanosensor Oxygen Measurement

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
Enrollment reduced 27% 96 → 70 participants
See other at-risk trials from Children's Hospital of Philadelphia

Record History

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  1. Primary and study completion pushed from Sep 2026 to Sep 2027 Show 5 more changesShow less
    • Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia
    • Enrollment reduced: 96 → 70 participants
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Past mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.
Trial Details
NCT Number NCT06819683
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 MItochondrial Myopathies, Mitochondrial Disease
Related terms Mitochondrial Diseases, Mitochondrial Myopathies
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov