NCT05445388

Brief Summary

Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

June 17, 2022

Last Update Submit

June 30, 2022

Conditions

Image, Body

Keywords

Middle Ear

Outcome Measures

Primary Outcomes (1)

  • Middle ear structures identified with the Aurisvue OCT device

    Identification of each of the following anatomical middle ear structures with Aurisvue: tympanic membrane, malleus, incus, stapes and promontory (visible or not visible)

    1 Year

Secondary Outcomes (1)

  • OCT-vibrometry measurements with the Aurisvue OCT device

    1 Year

Study Arms (1)

OCT imaging

EXPERIMENTAL

OCT imaging

Device: Aurisvue

Interventions

AurisvueDEVICE

OCT imaging of the middle ear

OCT imaging

Eligibility Criteria

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

You may qualify if:

  • age 18 or older
  • competent, willing and able to cooperate

You may not qualify if:

  • any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication
  • refusal to give informed consent
  • pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. R.M. Metselaar MD PhD

Study Record Dates

First Submitted

June 17, 2022

First Posted

July 6, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

July 6, 2022

Record last verified: 2022-06