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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство REFLEX ULTRA 45
  One time use for surgery

Первичные конечные точки

• Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Nasal Obstruction Symptom Evaluation (NOSE) score [Срок оценки: 7 days, 1 month, 6 months, 1 year, 2 years]
• 36-Item Short Form Survey (SF-36) [Срок оценки: 7 days, 3 months, 1 year, 2 years]
• Unilateral Nasal Resistance [Срок оценки: 3 months, 1 year, 2 years]
• Total Nasal Resistance [Срок оценки: 3 months, 1 year, 2 years]
• Minimal Cross-Sectional Area [Срок оценки: 3 months, 1 year, 2 years]
• Nasal Volume [Срок оценки: 3 months, 1 year, 2 years]
• Mucociliary Transport Function Time [Срок оценки: 3 months, 1 year, 2 years]
• Mucociliary Transport Function Distance [Срок оценки: 3 months, 1 year, 2 years]
• Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Anterior Rhinoscopy [Срок оценки: 7 days]
• Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Presence of Crusting and Bleeding by Anterior Rhinoscopy [Срок оценки: 7 days]
• Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Nasal Endoscopic Assessment [Срок оценки: 3 months, 1 year, 2 years]
• Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Magnetic Resonance Imaging (MRI) [Срок оценки: 3 months, 1 year, 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• The Third Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Henan Provincial People's Hospital — Чжэнчжоу
• Jiangsu Province Hospital — Нанкин
• China-Japan Union Hospital of Jilin University — Changchun
• Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07025304 · SNIS-E-1198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗