Radiofrequency Ablation Versus Lateralization as Office-Based Procedures for Bilateral Inferior Turbinate Hypertrophy

NCT07772505 | Completed FDA Device

• 1 other identifier: RFITLAT
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

: Patient Information Sheet and Informed Consent Form PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM (for adult subjects and interventional studies)

• 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

Conditions

Inferior Turbinates Hypertrophy; Nasal Obstruction

Keywords

Radiofrequency Ablation; Turbinate Lateralization; Turbinate Outfracture; Turbinates; Nasal Surgical Procedures; Office-Based Surgery; Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 1 week, 1 month, 3 months and 6 months post-procedure

Secondary Outcomes (1)

• Secondary outcome measures

  Baseline, 1 week, 1 month, 3 months, 6 months post-procedure

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

Patients with bilateral inferior turbinates hypertrophy who underwent radiofrequency ablation of inferior turbinates

Device: Radiofrequency ablation of inferior turbinates

Lateralization of inferior turbinates

ACTIVE COMPARATOR

Patients with bilateral inferior turbinates who underwent lateralization of inferior turbinates

Device: Lateralization of inferior turbinates

Interventions

Radiofrequency ablation of inferior turbinates DEVICE

Both are office procedures that can be done in clinic and we would like to determine the effectiveness of both.

Radiofrequency ablation

Lateralization of inferior turbinates DEVICE

Lateralization of inferior turbinates with freer elevator

Lateralization of inferior turbinates

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe deviated nasal septum or caudal dislocation Nasal polyposis Nasal valve disorder Allergy or contraindication to Marcaine (bupivacaine) with adrenaline, or to Co-Phenylcaine

Sponsors & Collaborators

• Goh Liang Chye: lead

Study Sites (1)

Tengku Ampuan Rahimah Hospital

Klang, Selangor, 41200, Malaysia

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Liang Chye Goh, MBBS, MS ORL HNS

  University of Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Patients will be allocated a number on registering for the research, such as (001,002,003,…180). By using the research randomixer online, participants will be randomly assigned to either group 1 or group 2. * Photographs of the inferior turbinates will be taken before and after procedures during each visit. The photographs will be assessed by 3 different surgeons, and the surgeons will not be informed on whether it is pre or post procedure. (outcome assessment blinding) * There should be no breaking of the randomization code as the end point accessors are the patients themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: To compare the effectiveness of lateralization Vs Radiofrequency Ablation for patients with bilateral inferior turbinate hypertrophy Randomized Comparative Study

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 19, 2026
• Study Start: November 17, 2020
• Primary Completion: January 17, 2022
• Study Completion: June 17, 2022
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)