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Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Larry B. Lundy, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01727544
First received: August 22, 2012
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Vestibular Dizziness
Superior Semicircular Canal Dehiscence
 Procedure: cartilage cap occlusion surgery
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • objective improvement [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 64
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical Group
patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
 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.
No Intervention: Non Surgical Group
patients meet the same criteria but will elect not to undergo surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medically unstable
  • pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727544

Contacts
Contact: Shannon Kennedy 904-953-7439 kennedy.shannon@mayo.edu

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Shannon Kennedy     904-953-7439     kennedy.shannon@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Larry Lundy, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Larry B. Lundy, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01727544     History of Changes
Other Study ID Numbers: 12-001953
Study First Received: August 22, 2012
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
superior semicircular canal
non-vestibular dizziness
vestibular dizziness

Additional relevant MeSH terms:
Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013