An interventional study of Radiofrequency ablation of inferior turbinates and Lateralization of inferior turbinates in Inferior Turbinates Hypertrophy and Nasal Obstruction, sponsored by Goh Liang Chye. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Goh Liang Chye · Not applicable, Interventional, and Treatment
: Patient Information Sheet and Informed Consent Form PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM (for adult subjects and interventional studies)
Title of study:
A Prospective, Randomized, Comparative Study between Lateralization Vs Radiofrequency Ablation for Patients with Bilateral Inferior Turbinates Hypertrophy
Name of investigator and institution:
Dr Ong Hui Yan (Principal Investigator), Jabatan Otorhinolaryngology, Pusat Purubatan Universiti Malaya/ Hospital Tengku Ampuan Rahimah Klang Dr Ng Jia Ji (Co-investigator), Jabatan Otorhinolaryngology, Hospital Tengku Ampuan Rahimah Dr Shashi Gopalan (Supervisor), Jabatan Otorhinolaryngology, Hospital Tengku Ampuan Rahimah
Name of sponsor:
This is a self-sponsored study
Introduction:
You are invited to participate in a research study because you have nose blockage which are not responding to medical treatment and may require surgical intervention. If you are not keen for operation in the operating theatre, we may offer procedures which can be done in clinic setting.
It is important that you understand why the research is being done and what it will involve. Please take your time to read through and consider this information carefully before you decide if you are willing to participate. Ask the study staff if anything is unclear or if you like more information. After you are properly satisfied that you understand this study, and that you wish to participate, you must sign this informed consent form. To participate in this study, you may be required to provide you doctor with information on your health history; you may harm yourself if you are not truthful with the information provided.
Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You may also refuse to answer any questions you do not want to answer. If you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal will still be used for the study. Your refusal to participate or withdrawal will not affect any medical or health benefits to which you are otherwise entitled.
This study has been approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia.
The purpose of this study is to compare between 2 clinic procedures which we perform under clinic setting for patients with nose obstruction due to enlarged turbinates. We are comparing the outcomes between these 2 procedures. This research can help us to decide on the most effective and safe procedure for patients with similar problem.
There are surgical interventions which are more effective from literature and we are performing them in the operating theatre, and requires full body anesthesia. If you are not keen for that, the 2 clinical procedures listed in this study will be an alternative. If you are agreeable for the study, you will only be subjected to only 1 of the procedures. The current procedure that we are rountinely doing now in our clinic is to shrink the turbinates by using a machine. Another procedure that we are comparing with is faster and requires only simple instrument.
Both of the procedures carry similar risks, such as pain, bleeding and crusting and recurrences. Both the procedures involved are performed in clinic and do not require admission.
180 participants will be included in this study.
The whole study will last about 3 months and your participation will be about 3 months.
6. What kind of study procedures will I receive?
If you agree to participate in the study, you will be randomly assigned to one of the treatment groups below. You have equal chance of being assigned to each of the group.
Group 1: Radiofrequency ablation of the inferior turbinates (using machine to burn and shrink the enlarged turbinates in your nose)
Group 2: Lateralization of the inferior turbinates (using an instrument to manipulate and push aside the turbinates)
Both of the procedures aim to reduce the size of the enlarged turbinates and to improve your nose blockage.
Both of the procedures carry similar risk and side-effects, such as pain, bleeding, crusting and recurrence of symptoms.
Only the principal investigator and the co-investigator will perform the procedure for you, and it will be supervised by the study supervisor.
7. What will happen if I decide to take part?
Purpose:
The investigators would like to compare the effectiveness of Radiofrequency ablation of inferior turbinates Vs Lateralization of inferior turbinates on patients with bilateral inferior turbinates, which could be carried out in clinic setting, to determine the best alternative treatment for patients who opt for surgical procedure under clinic setting.
Design:
This is a randomised, comparative, interventional study.
Method:
Patients with bilateral inferior turbinates hypertrophy from Tengku Ampuan Rahimah Hospital, who do not wish to undergo other forms of turbinates surgery under general anesthesia, and at the same time, fulfill the inclusion and exclusion criteria were recruited into this study. The participants were randomly assigned into the radiofrequency ablation group as well as the lateralization group. The effectiveness of the procedures was assessed via; NOSE scoring before and after procedures, the size of the inferior turbinates before and after procedures, pain and anxiety level during procedures as well as complications from the procedure respectively.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's enrollment of 54 is below the median of 70 across 139 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →This is the only study on the registry with Goh Liang Chye as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Bilateral inferior turbinate hypertrophy, Grade 3 or 4 (25% Inferior Turbinate Classification System) Age more than 18 years NOSE score more than 30 On conventional pharmacological therapy for more than 3 months
Exclusion Criteria:
Severe deviated nasal septum or caudal dislocation Nasal polyposis Nasal valve disorder Allergy or to Marcaine (bupivacaine) with adrenaline, or to Co-Phenylcaine
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with bilateral inferior turbinates hypertrophy who underwent radiofrequency ablation of inferior turbinates
Device: Radiofrequency ablation of inferior turbinates
Patients with bilateral inferior turbinates who underwent lateralization of inferior turbinates
Device: Lateralization of inferior turbinates
Both are office procedures that can be done in clinic and we would like to determine the effectiveness of both.
Lateralization of inferior turbinates with freer elevator
Primary outcome measures
1\. Change in Nasal Obstruction Symptom Evaluation (NOSE) Score Description: The total NOSE score ranges from a minimum of 0 to a maximum of 100 points on a scale, where higher scores indicate worse nasal obstruction (a more severe symptom burden). A successful outcome is defined as a reduction in score from a moderate/extreme level to a mild level. Measure Type: Mean Unit of Measure: score on a scale (0-100) Time Frame: Baseline, 1 week, 1 month, 3 months and 6 months post-procedure
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months post-procedure
Secondary outcome measures
Change in Inferior Turbinate Size Description: Inferior turbinate size will be assessed using the 25% Classification System, graded on a scale of 1 to 4, where higher grades indicate worse (larger) turbinate size. Measure Type: Mean Unit of Measure: grade on a scale (1-4)
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months post-procedure
Plan to share: No — to protect patients' anonymity and privacy
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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