Feasibility Evaluation of OtoSet | NCT04743817

Studies
Feasibility Evaluation of OtoSet

NCT04743817

Sponsor

SafKan

Status

Completed

Last Update Posted

May 12, 2022Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Cerumen Impaction of Both Ears

Interventions

OtoSet - Ear Cleaning System

Countries

United States

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 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2021Actual

Primary Completion Date

Oct 21, 2021Actual

Completion Date

Oct 21, 2021Actual

First Submitted Date

Feb 3, 2021

First Submission Date that Met QC Criteria

Feb 3, 2021

First Posted Date

Feb 8, 2021Actual

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 10, 2022

Last Update Posted Date

May 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OtoSet - Ear Cleaning Sytem	Experimental		Device: OtoSet - Ear Cleaning System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OtoSet - Ear Cleaning System	Device	Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System	OtoSet - Ear Cleaning Sytem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felice Anderson	Eclipse Clinical Research	Principal Investigator
Ronald Brazg, MD, FACE	Rainier Clinical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eclipse Clinical Research		Tucson	Arizona	85745	United States
Rainier Clinical Research Center

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