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| ID | Type | Description | Link |
|---|---|---|---|
| 1866 | Other Identifier | Ministry of Food and Drug Safety (MFDS) |
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This study is a prospective, multicenter, single-arm, open-label, non-randomized exploratory clinical trial designed to evaluate the safety and potential efficacy of an ultrasound stimulation device (NEFRONIX G-01) in patients with chronic kidney disease (CKD). Baseline functional assessments will be performed prior to intervention. Participants will receive ultrasound stimulation applied to the kidneys three times per week for four weeks according to the study protocol. Clinical evaluations will be conducted at baseline, at the end of treatment, and 12 weeks after completion of treatment. Renal function will be assessed using changes in estimated glomerular filtration rate based on serum creatinine (CKD-EPI eGFR Cr) and cystatin C (CKD-EPI eGFR CysC). Additional assessments will include imaging studies (Tc-99m DTPA renal scintigraphy and renal ultrasonography), urinalysis for proteinuria, inflammatory markers (high-sensitivity C-reactive protein), and renal injury biomarkers (neutrophil gelatinase-associated lipocalin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEFRONIX Treatment | Experimental | Participants in this arm will receive ultrasound stimulation using the NEFRONIX G-01 device applied to the kidneys three times per week for four weeks, in accordance with the study protocol. Standard clinical care for chronic kidney disease will be maintained throughout the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Stimulation (NEFRONIX G-01) | Device | Ultrasound stimulation will be delivered to the renal area using the NEFRONIX G-01 device. The intervention will be administered three times per week for four weeks in accordance with the study protocol. Standard clinical management for chronic kidney disease will be continued during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr) | The primary outcome is the change in glomerular filtration rate estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on serum creatinine (eGFR-EPI Cr) from baseline to after 4 weeks of application of the investigational medical device. | Baseline to after 4 weeks of application of the investigational medical device |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr) | Baseline to 12 weeks after application of the investigational medical device | |
| Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC) | Baseline to after 4 weeks of application of the investigational medical device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SungKyung Lee | Contact | 82+10-9877-8173 | sklee@deepsonbio.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC) | Baseline to 12 weeks after application of the investigational medical device |
| Change From Baseline in Urinary Protein Excretion | Baseline to after 4 weeks of application of the investigational medical device |
| Change From Baseline in Urinary Protein Excretion | Baseline to 12 weeks after application of the investigational medical device |
| Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Baseline to after 4 weeks of application of the investigational medical device |
| Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Baseline to 12 weeks after application of the investigational medical device |
| Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography | Baseline to after 4 weeks of application of the investigational medical device |
| Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography | Baseline to 12 weeks after application of the investigational medical device |
| Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration | Baseline to after 4 weeks of application of the investigational medical device |
| Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration | Baseline to 12 weeks after application of the investigational medical device |
| Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy | Baseline to after 4 weeks of application of the investigational medical device |
| Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy | Baseline to 12 weeks after application of the investigational medical device |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |