NCT01907243|CompletedPhase 3
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Sponsor study identifier
interventional
67
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
April 2013
Actual (reported)Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft is the gold standard. More recently, the spreader flap technique has been espoused as an alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a randomized trial setting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2012
Actual (reported)April 2013
Actual (reported)July 11, 2013
Actual (reported)July 24, 2013
Actual (reported)acoustic rhinometry ( minimum cross section area)
acoustic rhinomanometery GM (ARI model, U.K) with an ultrasound system 0/8. (US-100, Japan) All tests were done while the patients were sitting while holding the device before his nose, completely sealing the nose, without excessive pressure cause changing of the nasal shape. Reducing the possible mucosal effect on acoustic rhinomanometry results, all tests were performed 10 minutes after the decongestant (Oxymetasoline spray) usage. Finally, a graph was drawn with two notches wherein the first notch related the valve area and the second one related to anterior part of lower turbinate. Each examination consisted of three consecutives tests from which the minimum cross section area was calculated
before surgery
acoustic rhinometry ( minimum cross section area)
one year after surgery
Usage of spreader flap of upper lateral cartilage
performing of rhinoplasty without spreader flap
producing of upper lateral cartilage flap as a spreader flap
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Imam Khomeini Hospital
Tehran, Tehran Province, 94305, Iran
Babak Saaedi
Tehran University of Medical Sciences
67 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2013
First Posted
July 24, 2013
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
InFlux System for Nasal Breathing Improvement
Contact the study team to confirm eligibility.
Primary Completion
November 2012
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
July 24, 2013
Record last verified: 2013-07
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Source: ClinicalTrials.gov.
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