We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01727544
Recruitment Status : Withdrawn (Changed to a retrospective chart review)
First Posted : November 16, 2012
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Larry B. Lundy, 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.

Condition or disease Intervention/treatment Phase
Vestibular Dizziness Superior Semicircular Canal Dehiscence Procedure: cartilage cap occlusion surgery Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. objective improvement [ Time Frame: 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 :
  1. ABC Scale [ Time Frame: 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.

  2. VAS scores [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medically unstable
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727544


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Larry Lundy, MD Mayo Clinic

Responsible Party: Larry B. Lundy, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01727544     History of Changes
Other Study ID Numbers: 12-001953
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Larry B. Lundy, 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