Post-Market Clinical Study to Evaluate the Safety and Eff... | NCT07025304

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
REFLEX ULTRA 45	Experimental	The investigational product REFLEX ULTRA 45 includes two models which are EIC4845-01 and EICA4845-01. The only difference between these two models is the EICA4845-01 has a maximum two-use limit.	Device: REFLEX ULTRA 45

Name	Type	Description	Arm Group Labels	Other Names
REFLEX ULTRA 45	Device	One time use for surgery	REFLEX ULTRA 45

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months	Nasal Obstruction Symptom Evaluation (NOSE) consists of 5 questions regarding nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through nose, trouble sleeping, and ability to get enough air through nose during exercise or exertion. NOSE scores range from 0 to 100, with a higher score indicating a severe problem (i.e., worse outcome) and lower score indicating no problem (i.e., better outcome).	3 months

Secondary Outcomes

Measure	Description	Time Frame
Nasal Obstruction Symptom Evaluation (NOSE) score	Nasal Obstruction Symptom Evaluation (NOSE) consists of 5 questions regarding nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through nose, trouble sleeping, and ability to get enough air through nose during exercise or exertion. NOSE scores range from 0 to 100, with a higher score indicating a severe problem (i.e., worse outcome) and lower score indicating no problem (i.e., better outcome).

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Cathy Xiao	Contact	+86 18221637315		Cathy.xiao@smith-nephew.com
Julian Yang	Contact	+86 18101802151		Julian.yang@smith-nephew.com