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

October 30, 2014 updated by: SinuSys Corporation

SinuSys Patency of Maxillary Sinus Ostia Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, BC V6Z 1Y6
        • St. Paul's Hospital, ENT Department
  • United Kingdom
      • London, United Kingdom
        • Charing Cross Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Valley ENT
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • St. Elizabeth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SinuSys Dilation System
Maxillary Sinus Dilation
Device: SinuSys Dilation System
Sinuplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patency of Treated Area
Time Frame: Immediately post procedure
Immediately post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency of Treated Area
Time Frame: 3 months
Maxillary Sinus Ostia Patency of 33 patients analyzed.
3 months
Number of Participants With Device-related Adverse Events as a Measure of Safety
Time Frame: 3 months
3 months
Patency of Treated Area
Time Frame: 6 months
Maxillary Sinus Ostia Patency of 29 patients analyzed.
6 months
Patency of Treated Area
Time Frame: 12 months
Maxillary Sinus Ostia of 27 patients analyzed.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SinuSys Corporation

Investigators

  • Principal Investigator: Amin Javer, MD, St. Paul's Hospital
  • Principal Investigator: Peter Catalano, MD, St Elizabeth Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNS-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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