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Completed

NCT Number: NCT00939471

Safety and Efficacy of Balloon Sinuplasty in 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.

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Key information

Conditions

Chronic Sinusitis

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Relieva™ Balloon Sinuplasty™ System

Device

Balloon dilation will be performed using endoscopic equipment with video documentation capability.

Other names: Relieva

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Device Success: Ability to Access/Dilate Sinus Ostia

    Time frame: 12 months

    Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.

  2. Effectiveness: Medication Thru 1 yr

    Time frame: 12 months

    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.

  3. Effectiveness of Dilation/Measured by Post-op Interventions

    Time frame: 12 months

    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.

  4. Days Out of School During the 12 Months of Follow-up

    Time frame: 12 months

    Quantitative assessment of days out of school during the 12 months of follow-up.

  5. Revision Rate

    Time frame: at 1 year

    The number of subjects requiring revisions out of 33 subjects treated.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis

Acronym: INTACT

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jul 15, 2009
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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