Inferior Turbinates HypertrophyNCT07772505
Radiofrequency Ablation Versus Lateralization as Office-Based Procedures for Bilateral Inferior Turbinate Hypertrophy
A study testing Radiofrequency ablation of inferior turbinates and Lateralization of inferior turbinates in people with Inferior Turbinates Hypertrophy and Nasal Obstruction, run by Goh Liang Chye at 1 site in Malaysia.
Trial summary
: Patient Information Sheet and Informed Consent Form PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM (for adult subjects and interventional studies) 1. Title of study: A Prospective, Randomized, Comparative Study between Lateralization Vs Radiofrequency Ablation for Patients with Bilateral Inferior Turbinates… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inferior Turbinates Hypertrophy, Nasal Obstruction
- What is being tested?
- Radiofrequency ablation of inferior turbinates and Lateralization of inferior turbinates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Nov 2020to 17 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe deviated nasal septum or caudal dislocation Nasal polyposis Nasal valve disorder Allergy or contraindication to Marcaine (bupivacaine) with adrenaline, or to Co-Phenylcaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Ablation Versus Lateralization as Office-Based Procedures for Bilateral Inferior Turbinate Hypertrophy: A Randomized Comparative Study
: 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.
- What is the purpose of the study?
Read more
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.
- 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.
- What will happen if I decide to take part?
- You will first be examined on your nose condition by using a scope.
- The size of your turbinates will be documented.
- You will be given a set of questionnaire regarding your nose condition to fill up
- Your nose will be sprayed on either side, 2 puffs each of the decongestant spray.
- You will be given painkiller via injections over the inner side of your nose
- Cotton with medication will be inserted into your nose for 5 minutes
- Either 1 of the procedures will b performed
- After the procedure, you will be monitored for 15 minutes
Read the detailed description
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.
- Conditions
- Inferior Turbinates Hypertrophy, Nasal Obstruction
- Being tested
- Radiofrequency ablation of inferior turbinates, Lateralization of inferior turbinates
- Keywords
- Radiofrequency Ablation, Turbinate Lateralization, Turbinate Outfracture, Turbinates, Nasal Surgical Procedures, Office-Based Surgery, Local Anesthesia
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of inferior turbinatesDevice
Both are office procedures that can be done in clinic and we would like to determine the effectiveness of both.
Lateralization of inferior turbinatesDevice
Lateralization of inferior turbinates with freer elevator
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Active comparator | Patients with bilateral inferior turbinates hypertrophy who underwent radiofrequency ablation of inferior turbinates Receives: Device: Radiofrequency ablation of inferior turbinates |
| Lateralization of inferior turbinates | Active comparator | Patients with bilateral inferior turbinates who underwent lateralization of inferior turbinates Receives: Device: Lateralization of inferior turbinates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures
- 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
Measured: Baseline, 1 week, 1 month, 3 months and 6 months post-procedure
Secondary outcomes (1)
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)
Measured: Baseline, 1 week, 1 month, 3 months, 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start17 Nov 2020
- Primary completion17 Jan 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Turbinates HypertrophyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the effectiveness of lateralization Vs Radiofrequency Ablation for patients with bilateral inferior turbinate hypertrophy Randomized Comparative Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goh Liang Chye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goh Liang Chye, University of Malaya
- Investigators
- Liang Chye Goh, MBBS, MS ORL HNS, Study director, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772505
- Sponsor's protocol ID
- RFITLAT
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: to protect patients' anonymity and privacy
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Versus Lateralization as Office-Based Procedures for Bilateral Inferior Turbinate Hypertrophy: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07772505
- Acronym / sponsor ID
- RFITLAT
- Conditions
- Inferior Turbinates Hypertrophy, Nasal Obstruction
- Keywords
- Radiofrequency Ablation, Turbinate Lateralization, Turbinate Outfracture, Turbinates, Nasal Surgical Procedures, Office-Based Surgery, Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Goh Liang ChyeUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 19 Aug 2026 (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.
: 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.
- What is the purpose of the study?
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.
- 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.
- What will happen if I decide to take part?
- You will first be examined on your nose condition by using a scope.
- The size of your turbinates will be documented.
- You will be given a set of questionnaire regarding your nose condition to fill up
- Your nose will be sprayed on either side, 2 puffs each of the decongestant spray.
- You will be given painkiller via injections over the inner side of your nose
- Cotton with medication will be inserted into your nose for 5 minutes
- Either 1 of the procedures will b performed
- After the procedure, you will be monitored for 15 minutes
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- To compare the effectiveness of lateralization Vs Radiofrequency Ablation for patients with bilateral inferior turbinate hypertrophy Randomized Comparative Study
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Active comparator | Device: Radiofrequency ablation of inferior turbinatesPatients with bilateral inferior turbinates hypertrophy who underwent radiofrequency ablation of inferior turbinates |
| Lateralization of inferior turbinates | Active comparator | Device: Lateralization of inferior turbinatesPatients with bilateral inferior turbinates who underwent lateralization of inferior turbinates |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Severe deviated nasal septum or caudal dislocation Nasal polyposis Nasal valve disorder Allergy or contraindication to Marcaine (bupivacaine) with adrenaline, or to Co-Phenylcaine
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 |
|---|---|---|
| Radiofrequency ablation of inferior turbinatesBoth are office procedures that can be done in clinic and we would like to determine the effectiveness of both. | Device | Radiofrequency ablation |
| Lateralization of inferior turbinatesLateralization of inferior turbinates with freer elevator | Device | Lateralization of inferior turbinates |
Primary outcome
Primary outcome measures
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months post-procedure
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
1 secondary outcome
Secondary outcome measures
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. to protect patients' anonymity and privacy
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Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Active, not recruiting
Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis
Nasal Obstruction, Chronic Rhinitis
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Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
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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. This study is not recruiting at the moment.
Liang Chye Goh, MBBS, MS ORL HNS study director
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of inferior turbinates and Lateralization of inferior turbinates in people with Inferior Turbinates Hypertrophy and Nasal Obstruction, run by Goh Liang Chye at 1 site in Malaysia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures (time frame: Baseline, 1 week, 1 month, 3 months and 6 months post-procedure). 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 19 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.