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Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

This study has been withdrawn prior to enrollment.
(Changed to a retrospective chart review)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727544
First Posted: November 16, 2012
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Larry B. Lundy, Mayo Clinic
August 22, 2012
November 16, 2012
February 12, 2014
August 2012
August 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01727544 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vestibular Function Outcome After Cartilage Cap Occlusion Surgery
Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal
The primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.
One option for managing a dehiscent superior semicircular canal is surgical intervention. One of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.
Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Vestibular Dizziness
  • Superior Semicircular Canal Dehiscence
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.
  • Active Comparator: Surgical Group
    patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
    Intervention: Procedure: cartilage cap occlusion surgery
  • No Intervention: Non Surgical Group
    patients meet the same criteria but will elect not to undergo surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ambulatory
  • independent self-sufficient adults
  • good general health
  • medically stable

Exclusion Criteria:

  • Medically unstable
  • pregnant
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01727544
12-001953
No
Not Provided
Not Provided
Larry B. Lundy, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Larry Lundy, MD Mayo Clinic
Mayo Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP