NCT02463279

Brief Summary

The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

3 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, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

June 2, 2015

Last Update Submit

December 11, 2016

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Patency of treated target site

    Patency assessed by investigator via endoscopic evaluation of the target site

    Patency immediately post device expansion and removal

Secondary Outcomes (2)

  • Patency of treated target site

    1 month and 3 months

  • Reports of sinus related adverse events during the 3 months follow-up period

    up to 3 months

Study Arms (1)

SinuSys Dilation System

EXPERIMENTAL

Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)

Device: Sinusys Dilation System

Interventions

Sinusys Dilation SystemDEVICE

Dilation of frontal recess and/or sphenoid sinus ostia

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 CRS
  • Subject in in need of frontal recess and/or sphenoid sinus dilation

You may not qualify if:

  • Pregnant or breastfeeding females
  • Previous treatment site intervention
  • Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Upland ENT

Upland, California, 91786, United States

Location

Colorado ENT

Denver, Colorado, 80210, United States

Location

St. Elizabeth Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jerome Hester, MD

    SinuSys Chief Medical Officer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 4, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

US(3)