Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

NCT00939471 | Completed Results DMC

• 1 other identifier: CPR01918
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 months

Secondary Outcomes (5)

• Device Success: Ability to Access/Dilate Sinus Ostia

  12 months

• Effectiveness: Medication Thru 1 yr

  12 months

• Effectiveness of Dilation/Measured by Post-op Interventions

  12 months

• Days Out of School During the 12 Months of Follow-up

  12 months

• Revision Rate

  at 1 year

Study Arms (1)

Relieva™ Balloon Sinuplasty™ System

OTHER

Balloon Dilation of sinus ostium

Device: Relieva™ Balloon Sinuplasty™ System

Interventions

Relieva™ Balloon Sinuplasty™ System DEVICE

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

Also known as: Relieva

Relieva™ Balloon Sinuplasty™ System

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Results Point of Contact

• Title: Laura England, Manager-Clinical
• Organization: Acclarent, Inc.

lenglan1@its.jnj.com

650-687-4466

Study Officials

• Hassan Ramadan, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: April 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: May 1, 2010
• Last Updated: July 12, 2024
• Results First Posted: August 17, 2012

Record last verified: 2024-07

Locations

US (1)