Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

NCT ID: NCT01727544

Last Updated: 2014-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Vestibular Dizziness Superior Semicircular Canal Dehiscence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Group

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

Group Type ACTIVE_COMPARATOR

cartilage cap occlusion surgery

Intervention Type PROCEDURE

placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.

Non Surgical Group

patients meet the same criteria but will elect not to undergo surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Medically unstable
* pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Larry B. Lundy

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry Lundy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

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12-001953

Identifier Type: -

Identifier Source: org_study_id

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