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Mini muscle sensor could spot mitochondrial disease

NCT ID NCT04086329

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a small nanosensor placed under the skin in the forearm to measure oxygen levels in muscle, which reflects how well mitochondria are working. Researchers will compare results from 24 people—some with mitochondrial myopathy and some healthy—to see if the sensor can tell the difference. If it works, this tool could help diagnose mitochondrial diseases and evaluate new treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nanosensor device
What this could lead to
If successful, this could provide a new way to measure mitochondrial function in muscle, helping diagnose mitochondrial diseases and track treatment effects.
What could go wrong
This is a very early, small Phase 1 study with only 24 participants. The nanosensor has never been tested in humans before, so it may not work as expected or could cause discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Healthy Controls 1. Males and females, between the ages of 18 and 65 years, inclusive 2. Provide informed consent for study participation; able to understand and complete the protocol 3. Able to ambulate independently 4. Able to perform bicycle ergometry Inclusion Criteria for MM Cases 1. Males and females, between the ages of 18 and 65 years, inclusive 2. Provide informed consent for study participation; able to understand and complete the protocol 3. 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. 4. 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) 5. Able to ambulate independently 6. Able to perform bicycle ergometry Exclusion Criteria for All Participants Subjects will be excluded if any of the following apply: 1. Unable to provide informed consent and complete all study procedures, including ergometry 2. Non-ambulatory or unable to ambulate independently 3. Pregnant 4. Within 1 month of a recent hospital admission due to acute illness 5. 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 6. Have a tracheostomy 7. Have a known bleeding disorder and/or family history (first-degree relative) with a known bleeding disorder 8. Daily intake of aspirin or any other anti-platelet therapy which cannot be temporarily discontinued for medical reasons 9. 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 10. 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 11. Prone to hypertrophic scars and keloids 12. Have any other known inherited myopathy, such as Duchenne muscular dystrophy or congenital myopathy 13. Known allergy to lidocaine 14. Have a cognitive impairment that may prevent the ability to complete study procedures 15. 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 16. Individuals from vulnerable populations (e.g., prisoners/detainees) 17. Participants who are unable to speak and/or read English (as participants will be required to be proficient to complete study procedures)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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Other studies related to the condition(s) this trial covers.