Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China

Smith & Nephew

Status: Begins enrollment this month

Conditions: Nasal Obstruction Due to Inferior Turbinate Hypertrophy

Treatments: Device: REFLEX ULTRA 45

Study type: Interventional

Funder types: Industry

Identifiers

NCT07025304

SNIS-E-1198

Details and patient eligibility

About

The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01/EICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.

Full description

Inferior turbinate hypertrophy (ITH) is a common condition characterized by the enlargement of the inferior turbinate which is mainly due to swelling of the sub-mucosa and rarely due to enlargement of the bone itself. Based on current studies, there are several surgical techniques is being widely used in clinic for ITH includes turbinectomy, electrocautery, laser surgery, cryotherapy, Microdebrider-assisted inferior turbinoplasty (MAIT) and radiofrequency ablation (RFA). The technique used in this study for ITH is Coblation produced by REFLEX ULTRA 45. With limited high quality literature in Chinese population, it is the main purpose to generate high quality evidence among the Chinese population to establish the effectiveness and safety in Chinese population with sufficient outcomes evaluation and appropriate inclusion and exclusion criteria.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

REFLEX ULTRA 45

Experimental group

Description:

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.

Treatment:

Device: REFLEX ULTRA 45