FinESS Registry Study | NCT00849953

Studies
FinESS Registry Study

NCT00849953

Sponsor

Entellus Medical, Inc.

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Rhinosinusitis

Interventions

Not provided

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

Jun 2011

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 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 20, 2009

First Submission Date that Met QC Criteria

Feb 20, 2009

First Posted Date

Feb 24, 2009Estimated

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

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with FinESS Sinus Treatment using self-administered quality of life survey data.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FinESS Treatment		Subjects undergoing treatment with the FinESS Sinus Treatment System

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry

Exclusion Criteria:

none

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

Subjects who in the investigator's opinion, require trans-antral treatment of the maxillary sinus ostium and ethmoid infundibulum to remodel the bony sinus outflow tract using balloon displacement of adjacent bone and paranasal sinus structures using FinESS Sinus Treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeff Grebner	Entellus Medical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Denver ENT and Allergy		Denver	Colorado		United States
Gulf Coast Facial Plastics and ENR

Condition Browse Module

MeSH Terms

ID	Term
D000096825	Rhinosinusitis

Ancestor Terms

ID	Term
D012220	Rhinitis
D012141	Respiratory Tract Infections
D007239	Infections
D012852	Sinusitis

Browse Leaves

Not provided

Browse Branches

Not provided