Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax (Remo-Wax)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03802903|
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerumen Impaction of Both Ears||Device: Remo-Wax||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study|
|Actual Study Start Date :||March 12, 2019|
|Actual Primary Completion Date :||April 29, 2019|
|Actual Study Completion Date :||April 29, 2019|
Test product will be applied into ear canal for 20-60 minutes.
- Tympanic membrane visuality [ Time Frame: 20-60 minutes ]
Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application.
Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802903
|Vilnius, Lithuania, LT-06122|