Nasal Obstruction Due to Inferior Turbinate HypertrophyNCT07025304
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
A study testing REFLEX ULTRA 45 in people with Nasal Obstruction Due to Inferior Turbinate Hypertrophy, run by Smith & Nephew, Inc. at 6 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Obstruction Due to Inferior Turbinate Hypertrophy
- What is being tested?
- REFLEX ULTRA 45
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 6 sitesChina
- Study dates
- 2 Jul 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with at least two-year history of perennial rhinitis and who has failed standardized treatment with hormonal nasal spray before the planned 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.
Who cannot join
- 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, as confirmed by either MRI or endoscopy, than single inferior turbinate reduction
- Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.
- Subject who was treated with inferior turbinate reduction before informed consent.
Show all 12Show fewer
- 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.
- Subject who has participated previously in this clinical trial or who has been withdrawn.
- Subject with a history of poor compliance with medical treatment per investigator's opinion.
- Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
Dongdong Zhu, 0431-89876991, zhudd@jlu.edu.cn
Dongdong Zhu
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jian Li, 020-87608412, lijian7@mail.sysu.edu.cn
Jian Li
- Recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
Ointai Yang, 020-85252131, yangqint@mail.sysu.edu.cn
Ointai Yang
- Recruiting
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Mang Xiao, 0571-86006065, Joelxm@zju.edu.cn
Mang Xiao
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210003
Lei Cheng, 025-68303974, chenglei@jsph.org.cn
Lei Cheng
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 462000
Guangke Wang
0371-87160070, 13598895398@163.com
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- REFLEX ULTRA 45
- Keywords
- REFLEX, CITR, ITH, Coblation Inferior Turbinate Reduction, Inferior Turbinate Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLEX ULTRA 45Device
One time use for surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: REFLEX ULTRA 45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (14)
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).
Measured: 7 days, 1 month, 6 months, 1 year, 2 years
36-Item Short Form Survey (SF-36)
The 36-Item short form survey instrument taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Possible scores range from 0 to 100 for each item, with higher scores indicating a better outcome.
Measured: 7 days, 3 months, 1 year, 2 years
Unilateral Nasal Resistance
Nasal resistance is an objective indicator of nasal respiratory function, measured using a rhinomanometry device. During the assessment, the participant breathes air into a tube connected to the rhinomanometry device. The device measures the air pressure and rate of airflow, which are then used to calculate nasal resistance. Increased nasal resistance values indicate nasal obstruction. Unilateral nasal resistance measures the resistance to airflow through one nostril at a time.
Measured: 3 months, 1 year, 2 years
Total Nasal Resistance
Nasal resistance is an objective indicator of nasal respiratory function, measured using a rhinomanometry device. During the assessment, the participant breathes air into a tube connected to the rhinomanometry device. The device measures the air pressure and rate of airflow, which are then used to calculate nasal resistance. Increased nasal resistance values indicate nasal obstruction. Total nasal resistance measures the combined resistance to airflow through both nostrils simultaneously.
Measured: 3 months, 1 year, 2 years
Minimal Cross-Sectional Area
Minimal cross-sectional area (MCA) of the nasal passage will be measured using acoustic rhinometry. This technique provides detailed information on the geometry of the nasal cavity, identifying the narrowest part of the airway. MCA values will be recorded in square centimeters (cm^2) to assess how open the nasal passages are and potential obstructions.
Measured: 3 months, 1 year, 2 years
Nasal Volume
Nasal volume of the nasal cavity will be measured using acoustic rhinometry. Acoustic rhinometry is a standard diagnostic tool in objective evaluation of nasal patency. The information on the geometry of nasal cavities is provided using acoustic waves generated by the acoustic rhinometry device. It is an easy and non-painful procedure to perform. By placing a nosepiece into patient's nostril and performing breath holding, the information on the structure and dimensions of the nasal cavity is captured. Nasal volume values will be recorded in cubic centimeters (cm^3) to assess how open the nasal cavity is and potential obstructions.
Measured: 3 months, 1 year, 2 years
Mucociliary Transport Function Time
Mucociliary transportation function will be measured using a saccharin test. During this test a saccharin particle measuring 1mm in diameter is placed under direct vision, on the medial surface of the interior nasal turbinate. The time taken for the participant's initial perception of the sweet taste of saccharin will be recorded in minutes.
Measured: 3 months, 1 year, 2 years
Mucociliary Transport Function Distance
Mucociliary transportation function will be measured using a saccharin test or endoscopy. The distance from the saccharin placement site to the posterior wall of the pharynx could be measured by inserting a long cotton swab into the posterior wall of the nasopharynx of subject or nasal endoscopy.
Measured: 3 months, 1 year, 2 years
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Anterior Rhinoscopy
Anterior rhinoscopy is performed as a part of physical examination of turbinate/mucosal tissue health. The doctor wears a headlight to free up the hands and shines the light into the nose. A speculum is introduced into the nasal vestibule by the doctor to observe inferior turbinate, inferior meatus, and the upper part of the nasal cavity.
The anterior rhinoscopic assessment will help evaluate nasal mucosa, sinonasal anatomy and nasal pathology. Inferior turbinate hypertrophy assessed by anterior rhinoscopy to identify the degree of nasal obstruction will be categorized as one of the following grades:
- Grade 1: The inferior turbinate occupied less than half of the nasal cavity and no obvious nasal obstruction was observed
- Grade 2: Hypertrophied inferior turbinate occupied more than 50% of the nasal cavity
- Grade 3: A complete occlusion of the nasal cavity occurred because of the severe enlargement of the inferior turbinate
Measured: 7 days
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Presence of Crusting and Bleeding by Anterior Rhinoscopy
Anterior rhinoscopy is performed as a part of physical examination of turbinate/mucosal tissue health. The doctor wears a headlight to free up the hands and shines the light into the nose. A speculum is introduced into the nasal vestibule by the doctor to observe inferior turbinate, inferior meatus, and the upper part of the nasal cavity.
The anterior rhinoscopic assessment will help evaluate nasal mucosa, sinonasal anatomy and nasal pathology. Anterior rhinoscopy will be used to identify the presence of crusting and bleeding (Yes/No).
Measured: 7 days
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Nasal Endoscopic Assessment
Endoscope is a thin, flexible, or rigid tube with a tiny camera and a light. During the procedure, the doctor will put the endoscope into the patient's nose and guide it through the nasal and sinus passages. Image of the area is seen through the endoscope which helps evaluate nasal mucosa, sinonasal anatomy and nasal pathology.
Inferior turbinate hypertrophy assessed by the nasal endoscopic assessment to identify the degree of nasal obstruction will be categorized as one of the following grades:
- Grade 1: The inferior turbinate occupied less than half of the nasal cavity and no obvious nasal obstruction was observed
- Grade 2: Hypertrophied inferior turbinate occupied more than 50% of the nasal cavity
- Grade 3: A complete occlusion of the nasal cavity occurred because of the severe enlargement of the inferior turbinate
Measured: 3 months, 1 year, 2 years
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Magnetic Resonance Imaging (MRI)
MRI on the nasal cavity or paranasal sinuses will be used to evaluate turbinate/mucosal tissue health to identify presence of sinusitis, tumors, polyps, and deformities.
Measured: 3 months, 1 year, 2 years
Duration of Surgery
The time of surgery from start to end will be recorded.
Measured: During procedure
Intraoperative Bleeding
The blood loss during surgery will be categorized as one of the following: 0-5ml, 5-15ml or>15ml
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start2 Jul 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Obstruction Due to Inferior Turbinate HypertrophyStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongdong Zhu, Principal investigator, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025304
- Sponsor's protocol ID
- SNIS-E-1198
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07025304
- Acronym / sponsor ID
- SNIS-E-1198
- Keywords
- REFLEX, CITR, ITH, Coblation Inferior Turbinate Reduction, Inferior Turbinate Hypertrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REFLEX ULTRA 45 | Experimental | Device: REFLEX ULTRA 45The 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with at least two-year history of perennial rhinitis and who has failed standardized treatment with hormonal nasal spray before the planned 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.
Key exclusion criteria (12 listed)
- 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, as confirmed by either MRI or endoscopy, than single inferior turbinate reduction
- Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REFLEX ULTRA 45One time use for surgery | Device | REFLEX ULTRA 45 |
Primary outcome
Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months
Time frame: 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).
14 secondary outcomes
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: 7 days, 1 month, 6 months, 1 year, 2 years
36-Item Short Form Survey (SF-36)
Time frame: 7 days, 3 months, 1 year, 2 years
Unilateral Nasal Resistance
Time frame: 3 months, 1 year, 2 years
Total Nasal Resistance
Time frame: 3 months, 1 year, 2 years
Minimal Cross-Sectional Area
Time frame: 3 months, 1 year, 2 years
Nasal Volume
Time frame: 3 months, 1 year, 2 years
Mucociliary Transport Function Time
Time frame: 3 months, 1 year, 2 years
Mucociliary Transport Function Distance
Time frame: 3 months, 1 year, 2 years
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Anterior Rhinoscopy
Time frame: 7 days
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Presence of Crusting and Bleeding by Anterior Rhinoscopy
Time frame: 7 days
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Nasal Endoscopic Assessment
Time frame: 3 months, 1 year, 2 years
Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Magnetic Resonance Imaging (MRI)
Time frame: 3 months, 1 year, 2 years
Duration of Surgery
Time frame: During procedure
Intraoperative Bleeding
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dongdong Zhu principal investigator
China-Japan Union Hospital, Jilin University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REFLEX ULTRA 45 in people with Nasal Obstruction Due to Inferior Turbinate Hypertrophy, run by Smith & Nephew, Inc. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Xiao (+86 18221637315, Cathy.xiao@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.