Chronic RhinitisPhase 4NCT00737906
Surgical Reduction of the Inferior Turbinates for Nasal Obstruction
A Phase 4 study testing Surgical turbinate reduction procedure in people with Chronic Rhinitis and Inflammation of the Nasal Mucosa, run by ArthroCare Corporation at 5 sites in United States.
Trial summary
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Chronic Rhinitis, Inflammation of the Nasal Mucosa, Inflammation of Nasal Tissue
- What is being tested?
- Surgical turbinate reduction procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2007to Oct 2012
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is >=6 and <=17 years old.
- Patient has had symptoms of nasal obstruction for >=6 months.
- Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
- Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
- Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
- Patient (or guardian) must sign IRB approved informed consent form.
Who cannot join
- Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
- Septal deviation
- Concha bullosa
- Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)
- Nasal polyps
- Nasal valve collapse.
Show all 19Show fewer
- Patient has been diagnosed with obstructive sleep apnea not originating from the turbinates.
- Patient has active or chronic upper airway infection that may contribute to nasal obstruction (not including chronic rhinosinusitis).
- Patient has active coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery).
- Patient has systemic disease affecting the nasal passage(e.g. Wegener's granulomatosis).
- Patient is receiving or has received immunotherapy (any type) within 12 months of enrollment.
- Patient has a nasal septal perforation.
- Patient has had any previous turbinate surgery.
- Patient has had any previous nasal surgery.
- Patient has had any sinus surgery within 6 months of enrollment.
- Patient has had an adenoidectomy within 3 months of enrollment.
- Patient is pregnant or potentially pregnant.
- Patient or caregiver is incapable of understanding or responding to the study questionnaires.
- Patient is participating in another clinical study during the 12 month enrollment period.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Children's Hospital
Aurora, Colorado, 80045
Center for Pediatric ENT
Boynton Beach, Florida, 33437
Pediatric Otolaryngology Nationwide Children's Hospital
Columbus, Ohio, 43205
Advanced ENT & Allergy
Louisville, Kentucky, 40207
Children's Hospital of San Diego
San Diego, California, 92123
About this study
Official title: Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.
Read the detailed description
Chronic rhinitis, or inflammation of the nasal mucosa, is one of the most common causes of nasal obstruction in the pediatric population. Chronic rhinitis may result in mucous gland hypertrophy, engorgement of the vascular system and deposition of collagen in the nasal mucosa. These changes occur most prominently in the inferior turbinate, causing enlargement and nasal obstruction. In children, inferior turbinate hypertrophy is associated with a greater degree of nasal obstruction relative to adults because of their small nasal anatomy.
Cases that do not respond to conservative treatments may be considered for one of many surgical procedures, including turbinate excision, submucosal resection, submucosal cautery, laser treatment, cryosurgery, powered microdebridement, or radiofrequency-based ablation. Clinical studies have shown that bipolar radiofrequency-based plasma (Coblation®) devices are capable of creating focal submucosal lesions with minimal or no damage to structures adjacent to the treated area. At present, however, this technique has not been formally evaluated in children. This study will investigate whether surgical turbinate reduction performed using a Coblation device is associated with reduced nasal obstruction symptoms that has failed to improve with other treatment methodologies.
- Being tested
- Surgical turbinate reduction procedure
- Keywords
- Chronic rhinitis, Nasal Obstruction, Nasal Obstruction Symptoms, Failed Medical Management for Nasal Obstruction, Inflammation of the nasal mucosa, Pediatric Turbinate reduction, Coblation, Arthrocare, ENT, Failed Medical Management for Chronic Sinusitis, Turbinate, Inferior Turbinate Hypertrophy, Bilateral Inferior Turbinate Hypertrophy, Turbinate Hypertrophy, Inferior Turbinate, Bilateral Inferior Turbinate
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical turbinate reduction procedureProcedure or surgery
Surgical turbinate reduction using the COBLATION device
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Surgical turbinate reduction procedure Receives: Procedure: Surgical turbinate reduction procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.
Measured: 6 weeks, 6 months, 12 months
Secondary outcomes (2)
Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.
Measured: Through 12 months
To assess durability of treatment using: a. Self-reported obstructive symptoms measures b. Physical examination measures, d. Blinded evaluation of anterior rhinoscopy images
Measured: 6 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony M Magit, MD, Principal investigator, Children's Associated Medical Group, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737906
- Sponsor's protocol ID
- E-505DHH
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2008
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hol MK, Huizing EH. Treatment of inferior turbinate pathology: a review and critical evaluation of the different techniques. Rhinology. 2000 Dec;38(4):157-66.
PubMed 11190749Chang CW, Ries WR. Surgical treatment of the inferior turbinate: new techniques. Curr Opin Otolaryngol Head Neck Surg. 2004 Feb;12(1):53-7. doi: 10.1097/00020840-200402000-00015.
PubMed 14712123
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT00737906
- Acronym / sponsor ID
- E-505DHH
- Keywords
- Chronic rhinitis, Nasal Obstruction, Nasal Obstruction Symptoms, Failed Medical Management for Nasal Obstruction, Inflammation of the nasal mucosa, Pediatric Turbinate reduction, Coblation, Arthrocare
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2008 (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.
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.
Detailed description
Chronic rhinitis, or inflammation of the nasal mucosa, is one of the most common causes of nasal obstruction in the pediatric population. Chronic rhinitis may result in mucous gland hypertrophy, engorgement of the vascular system and deposition of collagen in the nasal mucosa. These changes occur most prominently in the inferior turbinate, causing enlargement and nasal obstruction. In children, inferior turbinate hypertrophy is associated with a greater degree of nasal obstruction relative to adults because of their small nasal anatomy.
Cases that do not respond to conservative treatments may be considered for one of many surgical procedures, including turbinate excision, submucosal resection, submucosal cautery, laser treatment, cryosurgery, powered microdebridement, or radiofrequency-based ablation. Clinical studies have shown that bipolar radiofrequency-based plasma (Coblation®) devices are capable of creating focal submucosal lesions with minimal or no damage to structures adjacent to the treated area. At present, however, this technique has not been formally evaluated in children. This study will investigate whether surgical turbinate reduction performed using a Coblation device is associated with reduced nasal obstruction symptoms that has failed to improve with other treatment methodologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Procedure: Surgical turbinate reduction procedureSurgical turbinate reduction procedure |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient is >=6 and <=17 years old.
- Patient has had symptoms of nasal obstruction for >=6 months.
- Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
- Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
- Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
Key exclusion criteria (19 listed)
- Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
- Patient has been diagnosed with obstructive sleep apnea not originating from the turbinates.
- Patient has active or chronic upper airway infection that may contribute to nasal obstruction (not including chronic rhinosinusitis).
- Patient has active coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery).
- Patient has systemic disease affecting the nasal passage(e.g. Wegener's granulomatosis).
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 |
|---|---|---|
| Surgical turbinate reduction procedureSurgical turbinate reduction using the COBLATION device | Procedure or surgery | I |
Primary outcome
Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.
Time frame: 6 weeks, 6 months, 12 months
2 secondary outcomes
Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.
Time frame: Through 12 months
To assess durability of treatment using: a. Self-reported obstructive symptoms measures b. Physical examination measures, d. Blinded evaluation of anterior rhinoscopy images
Time frame: 6 weeks, 6 months, 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 11190749Hol MK, Huizing EH. Treatment of inferior turbinate pathology: a review and critical evaluation of the different techniques. Rhinology. 2000 Dec;38(4):157-66.
- Background: PubMed 14712123Chang CW, Ries WR. Surgical treatment of the inferior turbinate: new techniques. Curr Opin Otolaryngol Head Neck Surg. 2004 Feb;12(1):53-7. doi: 10.1097/00020840-200402000-00015.
Related trials for Chronic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
RecruitingObservational study
The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis
Chronic Rhinitis
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.
Anthony M Magit, MD principal investigator
Children's Associated Medical Group, San Diego, CA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical turbinate reduction procedure in people with Chronic Rhinitis and Inflammation of the Nasal Mucosa, run by ArthroCare Corporation at 5 sites in United States.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire. (time frame: 6 weeks, 6 months, 12 months). 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 NCT00737906, which also lists 2 linked publications.
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 26 Aug 2015.