Patients With Chronic Rhinitis Who Failed Medical TreatmentCompareRFITNCT01054521
A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction
A study testing Bipolar RF in people with Patients With Chronic Rhinitis Who Failed Medical Treatment, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Chronic Rhinitis Who Failed Medical Treatment
- What is being tested?
- Bipolar RF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2010to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
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.
- Being tested
- Temperature-controlled RF, Bipolar RF
- Keywords
- radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-controlled RFProcedure or surgery
Also called Temperature-controlled RF device is Gyrus ENT.
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 RFDevice
Also called Bipolar RF device is Select Sutter.
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.
| Study group | Role | What they receive |
|---|---|---|
| Temperature-controlled RF (TCRF) | Experimental | 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. Receives: Procedure: Temperature-controlled RF |
| Bipolar RF (BRF) | Active comparator | 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. Receives: Device: Bipolar RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale scores of nasal obstructive symptom.
Measured: Up to 1 year follow-up
Secondary outcomes (2)
VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip
Shor-term at 4th week and long-term at 1 year follow-up
Measured: Up to 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
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
Measured: Up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Chronic Rhinitis Who Failed Medical TreatmentStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wish Banhiran, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054521
- Sponsor's protocol ID
- wbanhiran
- Acronym
- CompareRFIT
- Status last verified
- May 2014
- First submitted
- 21 Jan 2010
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Banhiran W, Assanasen P, Tantilipikorn P, Nujchanart N, Voraprayoon S, Bunnag C. A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2877-84. doi: 10.1007/s00405-014-3410-y. Epub 2014 Nov 29.
PubMed 25432641
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT01054521
- Acronym / sponsor ID
- CompareRFIT / wbanhiran
- Keywords
- radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jan 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature-controlled RF (TCRF) | Experimental | Procedure: Temperature-controlled RFThe 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. |
| Bipolar RF (BRF) | Active comparator | Device: Bipolar RFThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Temperature-controlled RFAlso: Temperature-controlled RF device is Gyrus ENT.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. | Procedure or surgery | Temperature-controlled RF (TCRF) |
| Bipolar RFAlso: Bipolar RF device is Select Sutter.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. | Device | Bipolar RF (BRF) |
Primary outcome
Visual Analog scale scores of nasal obstructive symptom.
Time frame: Up to 1 year follow-up
2 secondary outcomes
VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip
Time frame: Up to 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
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 2 Jun 2014.
- Derived from this study: PubMed 25432641Banhiran W, Assanasen P, Tantilipikorn P, Nujchanart N, Voraprayoon S, Bunnag C. A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2877-84. doi: 10.1007/s00405-014-3410-y. Epub 2014 Nov 29.
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.
Wish Banhiran, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar RF in people with Patients With Chronic Rhinitis Who Failed Medical Treatment, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 3 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 2 Jun 2014. 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 Thailand. 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?
Visual Analog scale scores of nasal obstructive symptom. (time frame: Up to 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01054521, which also lists 1 linked publication.
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 2 Jun 2014.