Simplus and Eson Non-Invasive Ventilation (NIV) Evaluatio... | NCT02726048

Studies
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

NCT02726048

Sponsor

Fisher and Paykel Healthcare

Status

Terminated

Last Update Posted

Aug 2, 2018Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Obesity Hypoventilation Syndrome
Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Neuromuscular Disease

Interventions

Simplus/Eson

Countries

Germany

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Fisher & Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 1, 2016Estimated

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

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Detailed Description

Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full face/Nasal masks	Experimental	Simplus/Eson	Device: Simplus/Eson

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simplus/Eson	Device	Released product Simplus and Eson masks	Full face/Nasal masks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Leak data	Obtained from the participant's device	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Subjective measurement of Leak	Questionnaire	2 weeks
Subjective measurement of Comfort	Questionnaire	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18+
Existing full face mask user or a nasal mask user
Prescribed NIV therapy for at least 3 months

Exclusion Criteria:

Inability to give informed consent
Pregnant or think they may be pregnant
Anatomical or physiological conditions making NIVtherapy inappropriate
Patients who are in a coma or decreased level of consciousness
Existing Simplus and Eson users

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
Ingo Fietze, Professor	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsmedizin Berlin		Berlin		10117	Germany

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
D010845	Obesity Hypoventilation Syndrome
D020181	Sleep Apnea, Obstructive
D029424	Pulmonary Disease, Chronic Obstructive
D009468	Neuromuscular Diseases

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided