NCT03131115|WithdrawnDMC
Study Stopped
Not able to enroll patient
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Sponsor study identifier
interventional
0
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2017
Actual (reported)April 27, 2017
Actual (reported)November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op
Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO)
1 year
Visual Analogue Scale for nasal obstruction
1 year
Visual analogue scale for satisfaction with appearance of the nose
1 year
physician derived lateral wall insufficiency grading system
1 year
Lateral crura strut graft is a well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage.
Bone- Anchored suspension is a well described surgical technique which involves anchoring the nasal sidewall to the bony rim below the eye.
surgical technique as described
Surgical technique as described
Division of Facial Plastics and Reconstructive Surgery, Stanford University
Palo Alto, California, 94304, United States
Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence). 2013 Summer;4(2):e66-8. doi: 10.2500/ar.2013.4.0054.
Sam P Most, MD
Stanford University
0 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2017
First Posted
April 27, 2017
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
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Most SP. Comparing Methods for Repair of the External Valve: One More Step Toward a Unified View of Lateral Wall Insufficiency. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):345-6. doi: 10.1001/jamafacial.2015.0790. No abstract available.
Primary Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 17, 2018
Record last verified: 2018-07
no plan to share IPD
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Source: ClinicalTrials.gov.
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