The purpose of this study is to compare the effectiveness of High-frequency therapy and HIFU(High Intensity Focused Ultrasound) therapy in patients with nasal congestion caused by inferior turbinate hypertrophy, and evaluate the safety.

Treatment

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 integrated ultrasonography system. If the patient agrees to participate in the test and write consent form for test subjects, and is selected as a test subject after a thorough review of the suitability of the study, the patients will receive a lower turbinate reduction with a clinical trial medical device or an existing high-frequency therapy at the second visit (baseline).In this clinical trial, the test group receiving inferior turbinate reduction with the clinical trial medical device “RHINOS” and the control group receiving inferior turbinate reduction with the existing high-frequency treatment device are divided into a 1:1 ratio with a 50% probability according to the prescribed rules of the clinical trial protocol.
After both groups undergo inferior turbinate reduction surgery, they visit the laboratory at 2th, 4th, and 12th weeks to observe the treatment area and collect data according to each item.

Arm Label

Target Number of Participant

Arm Type

Arm Description

A probe of the RHINOS is closely attached to the surface of the inferior turbinate to irradiate focused ultrasound from the inlet to the inferior turbinate. For RHINOS products, the Ultrasound frequency is 7MHz, the focusing distance is 3 mm, and the output is set to Level 5. The number of treatments is up to 300 shots, and the Treatment time is between 5 and 10 minutes.

Arm Label

Target Number of Participant

Arm Type

Arm Description

A probe of the coblator Device is reciprocated back and forth from the front part of the inferior turbinate, and the time is less than 1 minute per round trip, and the energy intensity is set to ablation 4~5 / coagulation 3, and the therapeutic range is the entire inferior turbinate.

Gender

Age

Description

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

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

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

Baseline, 2weeks after the baseline, 4weeks after the baseline, 12weeks after the baseline

To evaluate symptom relief through questionnaire evaluation at 12 weeks compared to baseline.

Baseline, 2weeks after the baseline, 4weeks after the baseline, 12weeks after the baseline

To evaluate the MCA value of the nasal airway test at 12 weeks compared to baseline.

Baseline, 2weeks after the baseline, 4weeks after the baseline, 12weeks after the baseline