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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01054521
First received: January 21, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Patients With Chronic Rhinitis Who Failed Medical Treatment
Procedure: Temperature-controlled RF
Device: Bipolar RF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Visual Analog scale scores of nasal obstructive symptom. [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: Yes ]
    Shor-term at 4th week and long-term at 1 year follow-up

  • Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: Yes ]
    Crusting was assessed at 1st week and 4th week, MTT at 4th week, and MCA, VOL, and NAR were assessed before and after treatment at 4th week and one year follow-up


Enrollment: 84
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.

Other Name: Temperature-controlled RF device is Gyrus ENT.
Active Comparator: 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.
Device: 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.
Other Name: Bipolar RF device is Select Sutter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054521

Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Wish Banhiran, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01054521     History of Changes
Other Study ID Numbers: wbanhiran
Study First Received: January 21, 2010
Last Updated: May 29, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
radiofrequency turbinate reduction
nasal obstruction
Temperature-controlled radiofrequency
Bipolar radiofrequency
chronic rhinitis.

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014