Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06819683 · ClinicalTrials.gov registry record · Phase 1
Validation of Nanosensor Oxygen Measurement
A Phase 1 study of Mitochondrial Disease and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT06819683: Recruiting Phase 1 study of Mitochondrial Disease and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
NCT06819683 is a Phase 1 study of Mitochondrial Disease and MItochondrial Myopathies that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 96 participants, below the 169-participant average among 5 other Mitochondrial Disease trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06819683, a Phase 1 study of Mitochondrial Disease and MItochondrial Myopathies, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 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-muscle oxygen (Torr) levels will be measure in the (dominant) forearm muscle during handgrip exercises and correlated to the standard measure of venous oxygenation (VO2) levels using standard clinical indirect calorimetry as a measure of tissue oxygen consumption. This data will be reported as the Torr value at each time point during measurement.
Conditions Studied
Interventions
- DEVICE Nanosensor
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What NCT06819683 shows while recruiting
NCT06819683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 169-participant average among 5 other Mitochondrial Disease trials with a reported enrollment target (43% lower).
The record links to 2 conditions, with Mitochondrial Disease appearing as the primary indexed condition, and to 1 intervention - of which Nanosensor is the first listed.
NCT06819683 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06819683 about?
NCT06819683 is a clinical study titled "Validation of Nanosensor Oxygen Measurement". 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 NCT06819683?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2025-01-02. Estimated completion is 2026-09.
What conditions does trial NCT06819683 study?
This clinical trial studies the following conditions: Mitochondrial Disease, MItochondrial Myopathies.
What interventions are being tested in trial NCT06819683?
The interventions under investigation include: Nanosensor (DEVICE).
Who is sponsoring clinical trial NCT06819683?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06819683 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitochondrial Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels
RECRUITING · Phase 1
-
Acute Infection in Mitochondrial Disease: Metabolism, Infection and Immunity
RECRUITING
-
Mitochondrial Dysfunction in Autism Spectrum Disorder
ACTIVE NOT RECRUITING
-
Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan
COMPLETED · NA
-
Mechanisms of Mitochondrial Defects in Gulf War Syndrome
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03401762 · 96 participants · NA
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- NCT03471260 · 96 participants · Phase 1
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT03549559 · 96 participants · NA
Imaging Histone Deacetylase in the Heart
- NCT03841058 · 96 participants · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI