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Tests treatment safety and results for Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Official title Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
ClinicalTrials.gov ID: NCT07025304
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal...
- Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation inferior turbinate reduction for bilateral nasal...
- 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...
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
- 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Nanjing, Jiangsu, China; Changchun, Jilin, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.