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

July 14, 2009
July 10, 2012
April 2007
July 2009   (final data collection date for primary outcome measure)
  • 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.
  • Safety: Sinus-related Adverse Events during balloon dilation through 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Effectiveness: Improvement in Sinus Symptom Scores [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00939471 on ClinicalTrials.gov Archive Site
  • 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.
  • Device Success: Ability to access/dilate sinus ostia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effectiveness: Medication thru 1 yr [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effectiveness of dilation/measured by post-op interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Days out of school [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Revision rate [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Sinusitis
Device: Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other Name: Relieva
Relieva™ Balloon Sinuplasty™ System
Balloon Dilation of sinus ostium
Intervention: Device: Relieva™ Balloon Sinuplasty™ System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00939471
CPR01918
Yes
Acclarent
Acclarent
Not Provided
Principal Investigator: Hassan Ramadan, MD West Virginia University
Acclarent
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP