NCT02435446

Brief Summary

Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis. The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT. In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis. The results of the CBCT will be compared to those of the CT scan.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 28, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

April 28, 2015

Last Update Submit

November 2, 2020

Conditions

Otosclerosis

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis

    1 minute

Study Arms (1)

Eligible patients for cone-beam

EXPERIMENTAL

A cone-beam computed tomography will be offered to the patients undergoing a CT scan for the diagnosis and/or the pre-operative assessment of an otosclerosis, fulfilling the inclusion criterias and without any exclusion criteria.

Device: Cone-beam computed tomography

Interventions

Cone-beam computed tomographyDEVICE

Cone-beam computed tomography

Eligible patients for cone-beam

Eligibility Criteria

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

You may qualify if:

  • CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis

You may not qualify if:

  • Pregnancy
  • Breast feeding
  • Patient under a legal protection procedure
  • Patient denying to participate to the study
  • Lack of affiliation to a social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Otosclerosis

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 6, 2015

Study Start

October 28, 2015

Primary Completion

October 2, 2017

Study Completion

October 2, 2017

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

FR(1)