Vestibular Function Outcome After Cartilage Cap Occlusion Surgery
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|ClinicalTrials.gov Identifier: NCT01727544|
Recruitment Status : Withdrawn (Changed to a retrospective chart review)
First Posted : November 16, 2012
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Dizziness Superior Semicircular Canal Dehiscence||Procedure: cartilage cap occlusion surgery||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Active Comparator: Surgical Group
patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
Procedure: cartilage cap occlusion surgery
placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.
No Intervention: Non Surgical Group
patients meet the same criteria but will elect not to undergo surgery
- objective improvement [ Time Frame: baseline to 3 months ]The primary outcome measure will be the subsequent (3 month) FGA scores between the control group and the surgery group to assess any objective improvement attributable to surgery
- ABC Scale [ Time Frame: baseline to 3 months ]Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.
- VAS scores [ Time Frame: baseline to 3 months ]Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727544
|Principal Investigator:||Larry Lundy, MD||Mayo Clinic|