Actively Recruiting
Validation of Nanosensor Oxygen Measurement
Led by Children's Hospital of Philadelphia · Updated on 2026-02-17
96
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of Nanosensor Oxygen Measurement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 65 years
- Able to provide informed consent and understand the study protocol
- Able to walk independently
- Able to perform bicycle exercise tests
- For mitochondrial myopathy cases: genetically confirmed diagnosis with symptoms of exercise intolerance, muscle weakness, and fatigue
- Previous or current enrollment in specified CHOP IRB studies
You will not qualify if you...
- Unable to provide informed consent or complete study procedures
- Unable to walk independently
- Pregnant
- Hospitalized for acute illness within the past month
- Severe heart disease with ejection fraction below 35% or severe lung disease requiring oxygen or ventilatory support
- Have a tracheostomy
- Known bleeding disorder or family history
- Taking aspirin or anti-platelet therapy that cannot be stopped
- Known or suspected immune deficiency or current immunosuppressive treatment
- History of recurrent severe skin infections or poor wound healing
- Chronic steroid use or untreated endocrine disorders causing myopathy
- Prone to hypertrophic scars or keloids
- Have other inherited muscle diseases like Duchenne muscular dystrophy
- Allergic to lidocaine
- Cognitive impairment interfering with study
- Unable to comply with study requirements
- Vulnerable populations such as prisoners
- Unable to speak or read English
- Employed by the U.S. Department of Defense or military personnel
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
Z
Zarazuela Zolkipli-Cunningham, MBChB, MRCP
CONTACT
D
Daniel McGinn, MS, LCGC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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