Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

NCT ID: NCT01623050

Last Updated: 2014-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Detailed Description

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A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Conditions

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Sinusitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SinuSys Dilation System

Maxillary Sinus Dilation

Group Type EXPERIMENTAL

SinuSys Dilation System

Intervention Type DEVICE

Sinuplasty

Interventions

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SinuSys Dilation System

Sinuplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-Diagnosis of chronic maxillary sinusitis

Exclusion Criteria

* Previous antrostomy
* Sinonasal tumours
* Cystic fibrosis
* History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
* Pregnant or breastfeeding females
* Currently participating in another drug or device study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SinuSys Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Catalano, MD

Role: PRINCIPAL_INVESTIGATOR

St Elizabeth Medical Center

Amin Javer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Locations

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Valley ENT

Tucson, Arizona, United States

Site Status

Palo Alto Medical Foundation

Palo Alto, California, United States

Site Status

St. Elizabeth Medical Center

Boston, Massachusetts, United States

Site Status

St. Paul's Hospital, ENT Department

Vancouver, British Columbia, Canada

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United States Canada United Kingdom

Other Identifiers

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SNS-005

Identifier Type: -

Identifier Source: org_study_id

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