NCT04743817

Brief Summary

This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

February 3, 2021

Last Update Submit

May 10, 2022

Conditions

Cerumen Impaction of Both Ears

Outcome Measures

Primary Outcomes (2)

  • Efficacy as Assessed by Occlusion Scale

    Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion)

    Treatment Visit (Day 1) (pre- to post-procedure)

  • Safety as Assessed by Adverse Events

    Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening)

    Treatment Visit (Day 1) through follow-up call (Day 2-4)

Study Arms (1)

OtoSet - Ear Cleaning Sytem

EXPERIMENTAL
Device: OtoSet - Ear Cleaning System

Interventions

OtoSet - Ear Cleaning SystemDEVICE

Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System

OtoSet - Ear Cleaning Sytem

Eligibility Criteria

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

You may qualify if:

  • Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
  • Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

You may not qualify if:

  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
  • Subject has life threatening illness
  • Subject has immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Study Officials

  • Felice Anderson

    Eclipse Clinical Research

    PRINCIPAL INVESTIGATOR

  • Ronald Brazg, MD, FACE

    Rainier Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

March 31, 2021

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)