Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT07025304
Eligibility Criteria:
Inclusion Criteria:
* Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal spray by the date of surgery.
* Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation inferior turbinate reduction for bilateral nasal cavity without outfracture of inferior turbinate per the investigator's judgement.
* Subject is 18 - 65 years old (inclusive).
* Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) approved consent form before any study procedures are performed, including pre- operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
* Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Exclusion Criteria:
* Subject who does not meet the indication or is contraindicated according to specific REFLEX ULTRA 45 's Instructions for Use (IFUs).
* Subject with obvious deviation of nasal septum with the necessity of surgery under investigator's judgement.
* Participation in the treatment period of another clinical trial within thirty (30) days of all visits completed.
* Subject who needs other nasal surgery other than single inferior turbinate reduction evaluated by MRI and nasal endoscopy.
* Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.
* Subject who was treated with inferior turbinate reduction before informed consent.
* Subjects who completed the Zung Self-Rating Anxiety Scale and the anxiety rate is more than 59.
* Woman who is pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
* Subject who has participated previously in this clinical trial or who has been withdrawn.
* Subject with a history of poor compliance with medical treatment.
* Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07025304
Study Brief:
Protocol Section:
NCT07025304