NCT01727544

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Shorter than P25 for early_phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

August 22, 2012

Last Update Submit

February 11, 2014

Conditions

Vestibular DizzinessSuperior Semicircular Canal Dehiscence

Keywords

superior semicircular canalnon-vestibular dizzinessvestibular dizziness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • ABC Scale

    baseline to 3 months

  • VAS scores

    baseline to 3 months

Study Arms (2)

Surgical Group

ACTIVE COMPARATOR

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

Procedure: cartilage cap occlusion surgery

Non Surgical Group

NO INTERVENTION

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

Interventions

cartilage cap occlusion surgeryPROCEDURE

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

Surgical Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Medically unstable
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Semicircular Canal Dehiscence

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Larry Lundy, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 22, 2012

First Posted

November 16, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02