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Taking people in United StatesPhase 1

Testing a small oxygen sensor to measure muscle energy function in mitochondrial disease

Tests an oxygen nanosensor in muscle of people with mitochondrial myopathy and healthy volunteers.

Key facts

Who runs it
Children's Hospital of Philadelphia
Where
Philadelphia, United StatesSee the site
Trial code
Registry title
Validation of Nanosensor Oxygen Measurement
Status
Recruiting
Phase
Phase 1
People taking part
70 people, planned
Started
2 Jan 2025
Expected to end
Sept 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Nanosensor
Record updated
7 October 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • Inclusion Criteria for Healthy Controls; Males and females, between the ages of 18 and 65 years, inclusive; Provide informed consent for study participation; able to understand and complete the protocol; Able to ambulate independently; Able to perform bicycle ergometry
  • Males and females, between the ages of 18 and 65 years, inclusive
  • Provide informed consent for study participation; able to understand and complete the protocol
  • Genetically-confirmed MM as defined by a diagnosis of primary mitochondrial disease (PMD) with predominant symptoms of myopathy as expressed by exercise intolerance and muscle weakness and fatigue
  • Previously enrolled (or will enroll) in Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) study #08-006177 (Falk, PI) or CHOP IRB #16-013364 (Zolkipli, PI)
  • Able to ambulate independently
  • Able to perform bicycle ergometry

Who cannot take part

  • Undergo chronic steroid treatment as defined by daily oral intake (for more than 1 month) or have existing untreated endocrinopathies, such as hypothyroidism that caused acquired myopathy
  • Within 1 month of a recent hospital admission due to acute illness
  • Have a known bleeding disorder and/or family history (first-degree relative) with a known bleeding disorder
  • Known allergy to lidocaine
  • Have a cognitive impairment that may prevent the ability to complete study procedures
  • Have severe cardiac disease as defined by an ejection fraction of less than 35% and New York Heart Association Functional Classification Class III; or severe pulmonary disease as defined by the need for supplemental O2 therapy or daytime ventilatory support
  • Daily intake of aspirin or any other anti-platelet therapy which cannot be temporarily discontinued for medical reasons
  • a) Have known or suspected congenital or acquired immune deficiency; b) concurrent use of immunosuppressive drugs, including corticosteroids; c) past history of recurrent (more than 6 times per year) severe (required hospitalization) skin or soft tissue infections; d) history of infection or delayed wound healing after surgery or biopsy; e) known history of neutropenia with absolute neutrophil count less than 500/mm3
  • Subjects will be excluded if any of the following apply:
  • Unable to provide informed consent and complete all study procedures, including ergometry
  • Non-ambulatory or unable to ambulate independently
  • Pregnant
  • Have a tracheostomy
  • Prone to hypertrophic scars and keloids
  • Have any other known inherited myopathy, such as Duchenne muscular dystrophy or congenital myopathy
  • Unable to comply with the requirements of the study protocol and/or unsuitable for the study for any reason, in the opinion of the principal investigator
  • Individuals from vulnerable populations (e.g., prisoners/detainees)
  • Participants who are unable to speak and/or read English (as participants will be required to be proficient to complete study procedures)
  • Employed by the U.S. Department of Defense, including U.S. military personnel

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • The Children's Hospital Of PhiladelphiaPhiladelphia, United StatesContact: Zarazuela Zolkipli-Cunningham, MBChB, MRCPTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Affected Mitochondrial Myopathy (MM) CasesTreatment being tested

    Key eligibility criteria for Mitochondrial Myopathy (MM) cases includes physically-capable adults (male and females, ages 18 to 65 years, inclusive) with genetically-confirmed MM with predominant symptoms of myopathy as expressed by exercise intolerance and muscle weakness and fatigue.

    Treatment: Nanosensor

  • Healthy ControlsExisting treatment, for comparison

    Adult healthy volunteers will be individually matched with corresponding Mitochondrial Myopathy cases based on age, biological sex, and body mass index.

    Treatment: Nanosensor

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Validation of Minimally Invasive Oxygen Nanosensor Technology to Quantify Mitochondrial Function in Human Muscle
Plain-language title
Testing a small oxygen sensor to measure muscle energy function in mitochondrial diseaseGenerated from the registry record. The registry title is the official one.
Fit questions
Built from NCT06819683, who can take part
Record updated
7 October 2026