NCT00737906|TerminatedPhase 4
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Sponsor study identifier
interventional
30
1 country
5
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
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.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2008
Actual (reported)August 20, 2008
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)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.
6 weeks, 6 months, 12 months
Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.
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
6 weeks, 6 months, 12 months
Surgical turbinate reduction procedure
Surgical turbinate reduction using the COBLATION device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children's Hospital of San Diego
San Diego, California, 92123, United States
The Children's Hospital
Aurora, Colorado, 80045, United States
Center for Pediatric ENT
Boynton Beach, Florida, 33437, United States
Advanced ENT & Allergy
Louisville, Kentucky, 40207, United States
Pediatric Otolaryngology Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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.
Chang 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.
Anthony M Magit, MD
Children's Associated Medical Group, San Diego, CA
30 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
August 26, 2015
Record last verified: 2015-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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