Clinical Trial

Validation of Oxygen Nanosensor in Mitochondrial Myopathy

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2019-09-09; most recent amendment 2026-02-16.
Status change: Not Yet Recruiting → Recruiting 2022-09-21
Trial Details
NCT Number NCT04086329
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Mitochondrial Myopathies, Mitochondrial Diseases
Enrollment 24 participants
Start Date 2023-01-17
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-18