The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJuly 24, 2013
July 1, 2013
2.3 years
July 19, 2013
July 23, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
three months after surgery
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
6 months after surgery
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
one year after surgery
Study Arms (3)
group B
ACTIVE COMPARATORmiddle turbinate resection
group C
ACTIVE COMPARATORmiddle turbinate medialization
group A
ACTIVE COMPARATORmiddle turbinate Radio Frequency (RF) turbinoplasty
Interventions
middle turbinate Radio Frequency (RF) turbinoplasty
Eligibility Criteria
You may qualify if:
- The patients with sinusitis who suffered from nasal polyposis which was resistant to maximal medical treatment (i.e. one puff of Fluticasone nasal spray twice daily plus amoxicillin clavulanic acid 625 mg tablet three times daily, for at least one month ).
You may not qualify if:
- floppy' change of the middle turbinate in the end of surgery.
- systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
- immune suppression,
- revision surgery,
- counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or
- any type of septoplasty indications are excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tehran University of Medical Sciences
Tehran, Tehran Province, 94305, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babak Saedi, professor
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 19, 2013
First Posted
July 24, 2013
Study Start
May 1, 2011
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
July 24, 2013
Record last verified: 2013-07