Chronic RhinosinusitisOASISNCT02347943

Global Sinus Surgery Registry

An observational study of Chronic Rhinosinusitis and Recurrent Acute Rhinosinusitis, run by Integra LifeSciences Corporation at 25 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Rhinosinusitis, Recurrent Acute Rhinosinusitis
How many people: 252 participants
Where: 25 sitesUnited States
Study dates: 1 Jan 2015to 1 Nov 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions
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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Albuquerque, New Mexico, 87109
Study site
Alexandria, Louisiana, 71303
Study site
Atlanta, Georgia, 30342
Study site
Berwyn, Illinois, 60402
Study site
Bethesda, Maryland, 20889
Study site
Chicago, Illinois, 60602
Study site
City of Saint Peters, Missouri, 63376
Study site
Evans, Georgia, 30809
Study site
Fort Wayne, Indiana, 46825
Study site
Fort Worth, Texas, 76104
Study site
Helena, Montana, 59601
Study site
Henderson, Nevada, 89052
Study site
Houston, Texas, 77098
Study site
Knoxville, Tennessee, 37934
Study site
Long Beach, New York, 11561
Study site
Los Angeles, California, 90048
Study site
McKinney, Texas, 75070
Study site
Miami, Florida, 33136
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10021
Study site
Phoenix, Arizona, 85032
Study site
Sacramento, California, 95815
Study site
San Antonio, Texas, 78249
Study site
San Francisco, California, 94108
Study site
West Burlington, Iowa, 52655

Other trials in United States

About this study

Official title: OASIS Global Sinus Surgery Registry

Conditions: Chronic Rhinosinusitis, Recurrent Acute Rhinosinusitis

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Completing Follow-Up Visits
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20151 Nov 2015

First posted28 Jan 2015 (estimated)
Study start1 Jan 2015
Primary completion1 Nov 2015
Study completion1 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347943
Sponsor's protocol ID: CPR005044
Acronym: OASIS
Status last verified: Jul 2024
First submitted: 19 Jan 2015
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps

All Chronic Rhinosinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OASIS Global Sinus Surgery Registry
ClinicalTrials.gov ID: NCT02347943
Acronym / sponsor ID: OASIS / CPR005044
Conditions: Chronic Rhinosinusitis, Recurrent Acute Rhinosinusitis
Study type: Observational
Recruitment status: Terminated
Enrolment: 252 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Acclarent
Study start: 1 Jan 2015 (actual)
Primary completion: 1 Nov 2015 (actual)
Study completion: 1 Nov 2015 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants Completing Follow-Up Visits
Time frame: 2 years

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Balloon Sinus Dilation	140	0
Endoscopic Sinus Surgery (ESS)	67	0
Hybrid	45	0

Primary outcome: Number of Participants Completing Follow-Up Visits

Time frame: 2 years

Population analysed: Due to early cancellation of the study data for this endpoint were not collected.

Adverse events

Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balloon Sinus Dilation (BSD)	1 of 140 (0.7%)	8 of 140 (5.7%)	Not reported
Endoscopic Sinus Surgery (ESS)	1 of 67 (1.5%)	4 of 67 (6%)	Not reported
Hybrid	0 of 45 (0%)	0 of 45 (0%)	Not reported

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Rhinosinusitis

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis and Recurrent Acute Rhinosinusitis, run by Integra LifeSciences Corporation at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Completing Follow-Up Visits (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.