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NCT04086329 · ClinicalTrials.gov registry record · Phase 1
Validation of Oxygen Nanosensor in Mitochondrial Myopathy
A Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04086329: Recruiting Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
NCT04086329 is a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 24 participants, below the 273-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04086329, a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Nanosensor measured muscle O2 levels at baseline, during handgrip exercise and after exercise
Conditions Studied
Interventions
- DEVICE Nanosensor
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 1 |
What NCT04086329 shows while recruiting
NCT04086329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 273-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Mitochondrial Diseases appearing as the primary indexed condition, and to 1 intervention - of which Nanosensor is the first listed.
NCT04086329 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04086329 about?
NCT04086329 is a clinical study titled "Validation of Oxygen Nanosensor in Mitochondrial Myopathy". 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 interve...
What is the current status of trial NCT04086329?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-01-17. Estimated completion is 2027-08-01.
What conditions does trial NCT04086329 study?
This clinical trial studies the following conditions: Mitochondrial Diseases, MItochondrial Myopathies.
What interventions are being tested in trial NCT04086329?
The interventions under investigation include: Nanosensor (DEVICE).
Who is sponsoring clinical trial NCT04086329?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04086329 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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