NCT01623050

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2012

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1 month until next milestone

Results Posted

Study results publicly available

October 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

June 13, 2012

Results QC Date

September 26, 2014

Last Update Submit

October 30, 2014

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Patency of Treated Area

    Immediately post procedure

Secondary Outcomes (4)

  • Patency of Treated Area

    3 months

  • Number of Participants With Device-related Adverse Events as a Measure of Safety

    3 months

  • Patency of Treated Area

    6 months

  • Patency of Treated Area

    12 months

Study Arms (1)

SinuSys Dilation System

EXPERIMENTAL

Maxillary Sinus Dilation

Device: SinuSys Dilation System

Interventions

SinuSys Dilation SystemDEVICE

Sinuplasty

SinuSys Dilation System

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic maxillary sinusitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Valley ENT

Tucson, Arizona, 85745, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

St. Elizabeth Medical Center

Boston, Massachusetts, 02135, United States

Location

St. Paul's Hospital, ENT Department

Vancouver, British Columbia, BC V6Z 1Y6, Canada

Location

Charing Cross Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Janie Mandrusov, Director of Pre-Clinical and Clinical Development
Organization
SinuSys Corporation
emandrusov@sinusys.com
4084104411

Study Officials

  • Peter Catalano, MD

    St Elizabeth Medical Center

    PRINCIPAL INVESTIGATOR

  • Amin Javer, MD

    St. Paul's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 19, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

September 1, 2014

Last Updated

November 5, 2014

Results First Posted

October 1, 2014

Record last verified: 2014-10

Locations

CA(1)GB(1)US(3)