Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653662
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2020-11-16
Brief Title:
Earol Madrid Study
Sponsor:
HL Healthcare Ltd
Organization:
HL Healthcare Ltd
Study Overview
Official Title:
Multi-center Open-label Non-randomized Single-arm Clinical Study to Assess the Safety and Performance of Earol in Adult Patients With Ear Wax
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMS
Brief Summary:
Accumulation of ear wax in the external ear canal is a common pathology The presence of ear wax not only interferes with the clinicians view of the tympanic membrane but may also result in hearing loss and vertigo and may predispose to ear infections
Removal of ear wax is facilitated using a variety of cerumenolytics or ear wax solvents The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure This study is designed to be conducted in the primary care setting as a prospective clinical trial
A detailed literature review has been conducted to provide a background summary of relevant information on the diseasepathology other available treatment options and the pre-clinical testing and clinical research that has been conducted to date on the intended population or related populations andor the device
The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol Although there are alternative methods for ear wax removal Earol represents a simple method based on natural ingredients olive oil which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal Eg reducing itching and irritation
Removal of ear wax is facilitated using a variety of cerumenolytics or ear wax solvents The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure This study is designed to be conducted in the primary care setting as a prospective clinical trial
A detailed literature review has been conducted to provide a background summary of relevant information on the diseasepathology other available treatment options and the pre-clinical testing and clinical research that has been conducted to date on the intended population or related populations andor the device
The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol Although there are alternative methods for ear wax removal Earol represents a simple method based on natural ingredients olive oil which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal Eg reducing itching and irritation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None