The clinical trial to evaluate the equivalence of bone age analyzed using the X-ray-based bone age and software medical device, GP Bio Solution, in pediatric subjects.

A multicenter, assessor-blinded, prospective, controlled, device comparison, confirmatory trial to evaluate the clinical equivalence of bone age analyzed by the TW3 method and bone age(Biometric data) analyzed by GP Bio Solution, a software as a medical device, in children undergoing first-time bone age assessment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010076

Enrollment

Registered

2024-12-20

Start date

2024-05-14

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The test device analyzes bone age (biometric data) using GP Bio Solution, which employs an artificial intelligence (AI) algorithm based on biometric information collected from physica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 7 to 13 years, both male and female 2. Children undergoing their first bone age assessment 3. Individuals who and their legal guardians have voluntarily given written consent to participate in the examination

Exclusion criteria

Exclusion criteria: 1. Pediatric individuals receiving growth treatment, such as growth hormone therapy. 2. Pediatric individuals diagnosed with true precocious puberty or pseudo-precocious puberty. 3. Pediatric individuals diagnosed with conditions that directly or indirectly cause short stature are not eligible to participate in the clinical trial: 4. Pediatric individuals diagnosed with achondroplasia. - Pediatric individuals with chromosomal abnormalities, such as Down syndrome or Turner syndrome. - Pediatric individuals with congenital metabolic disorders involving carbohydrate, amino acid, and lipid metabolism abnormalities. - Pediatric individuals diagnosed with congenital malformation syndromes associated with short stature, such as Russell-Silver syndrome, Prader-Willi syndrome, Noonan syndrome, and Laurence-Moon-Biedl syndrome. - Pediatric individuals diagnosed with genetic short stature. - Pediatric individuals diagnosed with chronic diseases such as congenital heart disease, cancer, chronic renal failure, chronic lung disease, malabsorption disorders, and liver disease. - Pediatric individuals diagnosed with psychosocial dwarfism, such as dependent depression. 4) Cases where there are other factors that may clinically affect the interpretation.

Design outcomes

Secondary

Measure	Time frame
1. Comparison of the bone age (biometric data) of the test device GP Bio Solution and the bone age of the control device TW3 in male subjects.;2. Comparison of the bone age (biometric data) of the test device GP Bio Solution and the bone age of the control device TW3 in female subjects. ;3. Exploratory comparison of the differences between chronological age and bone age, as well as between chronological age and bone age (biometric data).	—

Measure

Time frame

1. Comparison of the bone age (biometric data) of the test device GP Bio Solution and the bone age of the control device TW3 in male subjects.;2. Comparison of the bone age (biometric data) of the test device GP Bio Solution and the bone age of the control device TW3 in female subjects. ;3. Exploratory comparison of the differences between chronological age and bone age, as well as between chronological age and bone age (biometric data).

—

Primary

Measure	Time frame
Comparison of the bone age (biometric data) of the test device GP Bio Solution and the bone age of the control device TW3 for equivalence.	—

Countries

Korea, Republic of

Contacts

Public ContactKihwa Lee

Korea University Anam Hospital

oskh87@kumc.or.kr+82-2-920-6741

Outcome results