Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

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

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727544

Enrollment

Registered

2012-11-16

Start date

2012-08-31

Completion date

2013-08-31

Last updated

2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superior Semicircular Canal Dehiscence, Vestibular Dizziness

Keywords

superior semicircular canal, non-vestibular dizziness, vestibular dizziness

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.

Interventions

PROCEDUREcartilage 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Medically unstable * pregnant

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026