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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relieva™ Balloon Sinuplasty™ System
Sponsored by
Acclarent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Relieva™ Balloon Sinuplasty™ System

Arm Description

Balloon Dilation of sinus ostium

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Device Success: Ability to Access/Dilate Sinus Ostia
Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
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.
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.
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.
Revision Rate
The number of subjects requiring revisions out of 33 subjects treated.

Full Information

First Posted
July 14, 2009
Last Updated
August 4, 2017
Sponsor
Acclarent
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1. Study Identification

Unique Protocol Identification Number
NCT00939471
Brief Title
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Acronym
INTACT
Official Title
Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2007 (Actual)
Primary Completion Date
July 1, 2009 (Actual)
Study Completion Date
May 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acclarent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relieva™ Balloon Sinuplasty™ System
Arm Type
Other
Arm Description
Balloon Dilation of sinus ostium
Intervention Type
Device
Intervention Name(s)
Relieva™ Balloon Sinuplasty™ System
Other Intervention Name(s)
Relieva
Intervention Description
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Primary Outcome Measure Information:
Title
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
Description
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Time Frame
12 months
Title
Effectiveness: Change in Sinus Symptom Scores (SN-5)
Description
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.
Time Frame
12 months
Title
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Device Success: Ability to Access/Dilate Sinus Ostia
Description
Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
Time Frame
12 months
Title
Effectiveness: Medication Thru 1 yr
Description
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.
Time Frame
12 months
Title
Effectiveness of Dilation/Measured by Post-op Interventions
Description
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.
Time Frame
12 months
Title
Days Out of School During the 12 Months of Follow-up
Description
Quantitative assessment of days out of school during the 12 months of follow-up.
Time Frame
12 months
Title
Revision Rate
Description
The number of subjects requiring revisions out of 33 subjects treated.
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Ramadan, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

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