A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis

NCT07323888

Nasal Obstruction Chronic Rhinitis Nonallergic Rhinitis +2 more

NOT_YET_RECRUITING NA

Randomized Trial Comparing Partial Resection of Inferior Turbinate(PRIT) and Radiofrequency Ablation(RFA) for Inferior Turbinate Reduction

NCT00358267

Nasal Obstruction Septal Deformity Turbinate Hypertrophy

WITHDRAWN NA

Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

NCT05648565

Chronic Rhinitis

COMPLETED NA

The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

NCT05276336

Allergic Rhinitis

COMPLETED PHASE3

Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

NCT01827176

Acute Recurrent Sinusitis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Chronic Rhinitis Who Failed Medical Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Temperature-controlled RF (TCRF)

The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.

Group Type EXPERIMENTAL

Temperature-controlled RF

Intervention Type PROCEDURE

The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.

For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Bipolar RF (BRF)

The bipolar RF (BRF) probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Group Type ACTIVE_COMPARATOR

Bipolar RF

Intervention Type DEVICE

The bipolar RF probe will be inserted at the same area with TCRF. The energy used will be 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Temperature-controlled RF

The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.

For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Intervention Type PROCEDURE

Bipolar RF

The bipolar RF probe will be inserted at the same area with TCRF. The energy used will be 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Temperature-controlled RF device is Gyrus ENT. Bipolar RF device is Select Sutter.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults with snoring and chronic nasal obstruction.
* Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
* Consent to the protocol.

Exclusion Criteria

* Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
* Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
* Not complete the protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No