Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

Superior Semicircular Canal Dehiscence Clinical Trial

Official title:

Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01727544
• Other study ID #: 12-001953
• Status: Withdrawn
• Phase: Phase 0
• First received: August 22, 2012
• Last updated: February 11, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ambulatory

• independent self-sufficient adults

• good general health

• medically stable

Exclusion Criteria:

• Medically unstable

• pregnant

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Superior Semicircular Canal Dehiscence
• Vertigo
• Vestibular Dizziness

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline to 3 months	Yes
Secondary	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.	baseline to 3 months	No
Secondary	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.	baseline to 3 months	No