NCT07388966 Prospective Longitudinal Monocentric Study to Measure Limb Movement in Patients With FGFR3-related Skeletal Dysplasia
| NCT ID | NCT07388966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SYSNAV |
| Condition | Achondroplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-02-06 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to identify which Syde®-derived digital outcomes are reliable in FGFR3-related Skeletal Dysplasia. This requires to set-up a natural history study to measure limb movements in patients with ACH or HCH.
Eligibility Criteria
Inclusion Criteria: 1. Aged 3 years old or older at the time of consent. 2. Written informed consent obtained: 1. From the parent(s) or legal guardian(s) for participants under 18 years old. 2. From participants 18 years old and older. 3. Affiliated to, or beneficiary of a social security category 4. Able to walk unassisted for at least 10 meters. 5. Genetically confirmed diagnosis with one pathogenic variant (ACMG class IV \& V) of achondroplasia or hypochondroplasia. 6. Participant (and caregivers for participants under 18 years old) willing and able to comply with all study procedures including: questionnaires, Syde® related procedures Exclusion Criteria: 1. Subjects who have short stature condition other than ACH/HCH. 2. Presence of cognitive disorders that limit their understanding of the data collection process (training of device use and 4-week recording periods every 6 months, device return at the end of the study), the implication of the study and consent. 3. Presence or history of any concurrent disease or condition that could interfere with study participation, impact pediatric growth, affect motor or balance or gait function (such as neurological, endocrine, infectious, allergic, osteoarthritis, or inflammatory), assessed by the investigator. 4. Females who are pregnant, or planning to become pregnant during the study duration. 5. Body Mass Index = 35 kg/m2. 6. Recent upper and/or lower limbs injury (trauma/fracture or surgery) in the 6 months preceding inclusion. 7. Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study. 8. Presence of guided growth hardware (such as 8-plates) or planned orthopedic surgeries during the study. 9. Vulnerable patient (guardianship, curatorship or safeguarding of justice), unable to provide informed consent or who is unable to express their consent.
Contact & Investigator
Genevieve Baujat
PRINCIPAL INVESTIGATOR
Hopital Necker
Frequently Asked Questions
Who can join the NCT07388966 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 65 Years, studying Achondroplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07388966 currently recruiting?
Yes, NCT07388966 is actively recruiting participants. Contact the research team at ferial.toumi@sysnav.fr for enrollment information.
Where is the NCT07388966 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07388966 clinical trial?
NCT07388966 is sponsored by SYSNAV. The principal investigator is Genevieve Baujat at Hopital Necker. The trial plans to enroll 40 participants.