The Effect of Patient's Position After Intra-tympanic Inj... | NCT04384640

Studies
The Effect of Patient's Position After Intra-tympanic Injection

NCT04384640

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

May 12, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Sudden Hearing Loss

Interventions

Change of posture after Intra Tympanic injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

May 8, 2020

First Submission Date that Met QC Criteria

May 8, 2020

First Posted Date

May 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2020

Last Update Posted Date

May 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients seated after Intra-Tympanic injection			Other: Change of posture after Intra Tympanic injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Change of posture after Intra Tympanic injection	Other	Seating position after Intra Tympanic injection	Patients seated after Intra-Tympanic injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of taste	The patients will rate the degree of change of taste in their throat	0 Minutes, and then 10, 20, 30 minutes after the injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
Patients who signed an informed consent form

Exclusion Criteria:

Dysgeusia
Inner or middle ear malfomation
Eustachian tube dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
‪Yahav Oron	Contact	0523523181		oron.yahav@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003639	Hearing Loss, Sudden

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided