Chronic SinusitisINTACTNCT00939471
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A study testing Relieva™ Balloon Sinuplasty™ System in people with Chronic Sinusitis, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Relieva™ Balloon Sinuplasty™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2007to 1 May 2010
- Phase
- Interventional
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age > 2 and < 18 years
- Both male and female patients eligible
- Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
- Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Who cannot join
- Extensive previous sinonasal surgery in target ostia
- Cystic fibrosis
- Extensive sinonasal osteoneogenesis
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- For female patients of childbearing age: the patient is either pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Conditions
- Chronic Sinusitis
- Being tested
- Relieva™ Balloon Sinuplasty™ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relieva™ Balloon Sinuplasty™ SystemDevice
Also called Relieva
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
| Study group | Role | What they receive |
|---|---|---|
| Relieva™ Balloon Sinuplasty™ System | Other | Balloon Dilation of sinus ostium Receives: Device: Relieva™ Balloon Sinuplasty™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Measured: 12 months
Effectiveness: Change in Sinus Symptom Scores (SN-5)
Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
Measured: 12 months
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.
Measured: 12 months
Secondary outcomes (5)
Device Success: Ability to Access/Dilate Sinus Ostia
Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
Measured: 12 months
Effectiveness: Medication Thru 1 yr
Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.
Measured: 12 months
Effectiveness of Dilation/Measured by Post-op Interventions
Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.
Measured: 12 months
Days Out of School During the 12 Months of Follow-up
Quantitative assessment of days out of school during the 12 months of follow-up.
Measured: 12 months
Revision Rate
The number of subjects requiring revisions out of 33 subjects treated.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study start1 Apr 2007
- Primary completion1 Jul 2009
- Study completion1 May 2010
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 SinusitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Hassan Ramadan, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939471
- Sponsor's protocol ID
- CPR01918
- Acronym
- INTACT
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2009
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
- ClinicalTrials.gov ID
- NCT00939471
- Acronym / sponsor ID
- INTACT / CPR01918
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 1 Jul 2009 (actual)
- Study completion
- 1 May 2010 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relieva™ Balloon Sinuplasty™ System | Other | Device: Relieva™ Balloon Sinuplasty™ SystemBalloon Dilation of sinus ostium |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age > 2 and < 18 years
- Both male and female patients eligible
- Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
- Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Key exclusion criteria (7 listed)
- Extensive previous sinonasal surgery in target ostia
- Cystic fibrosis
- Extensive sinonasal osteoneogenesis
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relieva™ Balloon Sinuplasty™ SystemAlso: RelievaBalloon dilation will be performed using endoscopic equipment with video documentation capability. | Device | Relieva™ Balloon Sinuplasty™ System |
Primary outcome
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
Time frame: 12 months
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Effectiveness: Change in Sinus Symptom Scores (SN-5)
Time frame: 12 months
Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
Time frame: 12 months
Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.
5 secondary outcomes
Device Success: Ability to Access/Dilate Sinus Ostia
Time frame: 12 months
Effectiveness: Medication Thru 1 yr
Time frame: 12 months
Effectiveness of Dilation/Measured by Post-op Interventions
Time frame: 12 months
Days Out of School During the 12 Months of Follow-up
Time frame: 12 months
Revision Rate
Time frame: at 1 year
Results and safety
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.
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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.
Hassan Ramadan, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relieva™ Balloon Sinuplasty™ System in people with Chronic Sinusitis, run by Integra LifeSciences Corporation at 1 site 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 4 inclusion and 7 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: finished, 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 1 site 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 17 Aug 2012). 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?
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.