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Multi-center, Randomized, Proof of concept clinical trials for therapeutic efficacy and safety of the High intensity Focused ultrasound stimulators (RHINOS) in patients with severe Nasal congestion by hypertrophy

Multi-center, Randomized, Proof of concept clinical trials for therapeutic efficacy and safety of the High intensity Focused ultrasound stimulators (RHINOS) in patients with severe Nasal congestion by hypertrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005727
Enrollment
20
Registered
2020-12-31
Start date
2021-03-31
Completion date
Unknown
Last updated
2025-09-22

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 medical devices used in this test will verify the clinical efficacy and safety of nasal congestion treatment in patients with nasal congestion caused by hypoglycemia through the i

Sponsors

Korust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Adult men and women aged 19 to 70 years old 2. A person who voluntarily decides to participate in this clinical trial and signs a voluntary written consent for participation in the study 3. Patients with nasal congestion symptoms (Visual Analog Scale: 4 points or more) 4. Patients with confirmed inferior turbinate enlargement through nasal endoscopy 5. Patients who received drug treatment (topical corticosteroid, antihistamine, systemic decongestant, etc.) for more than 3 months, but the symptoms of nasal congestion did not improve

Exclusion criteria

Exclusion criteria: 1. Patients with severe septal curvature 2. Patients accompanied by rhinosinusitis 3. Patients with acute upper respiratory infection (cold, acute sinusitis, etc.) 4. Patients who have undergone surgery related to rhinitis (lower turbinate reduction, septal correction, etc.) 5. Patients accompanied by severe systemic disease (malignant tumors, anemia, active pulmonary tuberculosis, infections, drug addiction, paralysis, mental illness, identified or identified on the research director and co-researcher charts or during interviews) 6. Patients related to the researcher conducting the clinical evaluation 7. Pregnant or lactating patients 8. illiterate people 9. Patients judged by the researcher as unsuitable for participation in clinical trials

Design outcomes

Primary

MeasureTime frame
Changes in the patient's nasal congestion symptom score(Visual analog scale, 0~10) at 12 weeks compared to baseline

Secondary

MeasureTime frame
To evaluate symptom relief through questionnaire evaluation at 12 weeks compared to baseline.;To evaluate the MCA value of the nasal airway test at 12 weeks compared to baseline.

Countries

Korea, Republic of

Contacts

Public ContactDooHee Han

Seoul National University Hospital

enthan@naver.com+82-31-787-7401

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026