An interventional study of REFLEX ULTRA 45 in Nasal Obstruction Due to Inferior Turbinate Hypertrophy, sponsored by Smith & Nephew, Inc.. Recruiting at 6 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Smith & Nephew, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
One time use for surgery
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).
Time frame: 3 months
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 3 months, 1 year, 2 years
Duration of Surgery
The time of surgery from start to end will be recorded.
Time frame: During procedure
Intraoperative Bleeding
The blood loss during surgery will be categorized as one of the following: 0-5ml, 5-15ml or\>15ml
Time frame: During procedure
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Smith & Nephew, Inc.