Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

Early Phase 1

Withdrawn

• Conditions: Vestibular Dizziness; Superior Semicircular Canal Dehiscence
• Interventions: Procedure: cartilage cap occlusion surgery

• Registration Number: NCT01727544
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Medically unstable
• pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Group	cartilage cap occlusion surgery	patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.

Primary Outcome Measures

Name	Time	Method
objective improvement	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

Secondary Outcome Measures

Name	Time	Method
ABC Scale	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	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.