Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00939471
First received: July 14, 2009
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Chronic Sinusitis
Device: Relieva™ Balloon Sinuplasty™ System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Device Success: Ability to Access/Dilate Sinus Ostia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.

  • Effectiveness: Medication Thru 1 yr [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Effectiveness of Dilation/Measured by Post-op Interventions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Days Out of School During the 12 Months of Follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quantitative assessment of days out of school during the 12 months of follow-up.

  • Revision Rate [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    The number of subjects requiring revisions out of 33 subjects treated.


Enrollment: 44
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Relieva™ Balloon Sinuplasty™ System
Balloon Dilation of sinus ostium
Device: Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other Name: Relieva

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 2 and < 18 years
  2. Both male and female patients eligible
  3. 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)
  4. Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan

Exclusion Criteria:

  1. Extensive previous sinonasal surgery in target ostia
  2. Cystic fibrosis
  3. Extensive sinonasal osteoneogenesis
  4. Sinonasal tumors or obstructive lesions
  5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
  6. Ciliary dysfunction
  7. For female patients of childbearing age: the patient is either pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939471

Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Hassan Ramadan, MD West Virginia University
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00939471     History of Changes
Other Study ID Numbers: CPR01918
Study First Received: July 14, 2009
Results First Received: July 20, 2011
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014