Nasal ObstructionNCT06612450
Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience
A study testing turbinate surgery in people with Nasal Obstruction and Turbinate Surgery, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Obstruction, Turbinate Surgery
- What is being tested?
- turbinate surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Aug 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients with the following criteria were eligible for inclusion:
- Age group: 18-60 years old.
- Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
- Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
- Patients who are unfit for general anesthesia
Who cannot join
- All Patients with:
- Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafr El-Sheikh Universitty
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 6850001
About this study
The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year
- Conditions
- Nasal Obstruction, Turbinate Surgery
- Being tested
- turbinate surgery
- Keywords
- Turbinate Hypertrophy, Coblation, Radiofrequency, Nasal obstruction
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turbinate surgeryDevice
Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function
| Study group | Role | What they receive |
|---|---|---|
| Coblation | Active comparator | patients will undergo turbinoplasty using coblation wand Receives: Device: turbinate surgery |
| RaVoR | Active comparator | patients will undergo turbinate reduction using ravor radiofrequency Receives: Device: turbinate surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOSE score
nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Measured: 1 year
Pain VAS score
patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain
Measured: 1-3 months postoperative
Turbinate Size grading
endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jun 2022
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim M. Gehad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612450
- Sponsor's protocol ID
- MKSU200-289
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: will be shared with results
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience
- ClinicalTrials.gov ID
- NCT06612450
- Acronym / sponsor ID
- MKSU200-289
- Conditions
- Nasal Obstruction, Turbinate Surgery
- Keywords
- Turbinate Hypertrophy, Coblation, Radiofrequency, Nasal obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- 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 purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coblation | Active comparator | Device: turbinate surgerypatients will undergo turbinoplasty using coblation wand |
| RaVoR | Active comparator | Device: turbinate surgerypatients will undergo turbinate reduction using ravor radiofrequency |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group: 18-60 years old.
- Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
- Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
- Patients who are unfit for general anesthesia
Key exclusion criteria (2 listed)
- All Patients with:
- Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study
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 |
|---|---|---|
| turbinate surgeryTurbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function | Device | Coblation, RaVoR |
Primary outcome
NOSE score
Time frame: 1 year
nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Pain VAS score
Time frame: 1-3 months postoperative
patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain
Turbinate Size grading
Time frame: 1 year postoperative
endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity
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 25 Sep 2024.
- Individual participant dataSharing planned: Yes. will be shared with results
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing turbinate surgery in people with Nasal Obstruction and Turbinate Surgery, run by Kafrelsheikh University at 1 site in Egypt.
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 5 inclusion and 2 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 25 Sep 2024. 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 Egypt. 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?
NOSE score (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024.