Back to resultsVestibular Function Outcome After Cartilage Cap Occlusion Surgery
Primary Purpose
Vestibular Dizziness, Superior Semicircular Canal Dehiscence
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
cartilage cap occlusion surgery
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Dizziness focused on measuring superior semicircular canal, non-vestibular dizziness, vestibular dizziness
Eligibility Criteria
Inclusion Criteria:
- ambulatory
- independent self-sufficient adults
- good general health
- medically stable
Exclusion Criteria:
- Medically unstable
- pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Surgical Group
Non Surgical Group
Arm Description
patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
patients meet the same criteria but will elect not to undergo surgery
Outcomes
Primary Outcome Measures
objective improvement
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
Secondary Outcome Measures
ABC Scale
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01727544
Brief Title
Vestibular Function Outcome After Cartilage Cap Occlusion Surgery
Official Title
Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Changed to a retrospective chart review
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Dizziness, Superior Semicircular Canal Dehiscence
Keywords
superior semicircular canal, non-vestibular dizziness, vestibular dizziness
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical Group
Arm Type
Active Comparator
Arm Description
patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
Arm Title
Non Surgical Group
Arm Type
No Intervention
Arm Description
patients meet the same criteria but will elect not to undergo surgery
Intervention Type
Procedure
Intervention Name(s)
cartilage cap occlusion surgery
Intervention Description
placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.
Primary Outcome Measure Information:
Title
objective improvement
Description
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
Time Frame
baseline to 3 months
Secondary Outcome Measure Information:
Title
ABC Scale
Description
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.
Time Frame
baseline to 3 months
Title
VAS scores
Description
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.
Time Frame
baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ambulatory
independent self-sufficient adults
good general health
medically stable
Exclusion Criteria:
Medically unstable
pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Lundy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vestibular Function Outcome After Cartilage Cap Occlusion Surgery
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