NCT02347943

Brief Summary

This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

25 active sites

Status
terminated

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

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 27, 2019

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

January 19, 2015

Results QC Date

June 9, 2017

Last Update Submit

July 10, 2024

Conditions

Chronic RhinosinusitisRecurrent Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Completing Follow-Up Visits

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.

You may qualify if:

  • Age ≥ 18 years or minimum adult age as required by local regulations
  • The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure
  • Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines
  • The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form
  • Subject is able to read and understand local language

You may not qualify if:

  • Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III
  • Planned external approaches (i.e. not trans-nasal)
  • Planned off-label usage of balloon sinus dilation products.
  • Balloon sinus dilation performed with a non-Acclarent balloon product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Phoenix, Arizona, 85032, United States

Location

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Sacramento, California, 95815, United States

Location

Unknown Facility

San Francisco, California, 94108, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Evans, Georgia, 30809, United States

Location

Unknown Facility

Berwyn, Illinois, 60402, United States

Location

Unknown Facility

Chicago, Illinois, 60602, United States

Location

Unknown Facility

Fort Wayne, Indiana, 46825, United States

Location

Unknown Facility

West Burlington, Iowa, 52655, United States

Location

Unknown Facility

Alexandria, Louisiana, 71303, United States

Location

Unknown Facility

Bethesda, Maryland, 20889, United States

Location

Unknown Facility

City of Saint Peters, Missouri, 63376, United States

Location

Unknown Facility

Helena, Montana, 59601, United States

Location

Unknown Facility

Henderson, Nevada, 89052, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87109, United States

Location

Unknown Facility

Long Beach, New York, 11561, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Knoxville, Tennessee, 37934, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Fort Worth, Texas, 76104, United States

Location

Unknown Facility

Houston, Texas, 77098, United States

Location

Unknown Facility

McKinney, Texas, 75070, United States

Location

Unknown Facility

San Antonio, Texas, 78249, United States

Location

Limitations and Caveats

Due to the early cancellation of the study, study results reported are limited to subject enrollment, subject demographics, and Adverse Events (SAE and Non-serious).

Results Point of Contact

Title
Patricia Chen
Organization
Acclarent, Inc
pchen126@its.jnj.com
949-453-6408

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 12, 2024

Results First Posted

February 27, 2019

Record last verified: 2024-07

Locations

US(25)