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Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01990820
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : October 1, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
NorthShore University HealthSystem

Tracking Information
First Submitted Date  ICMJE November 16, 2013
First Posted Date  ICMJE November 21, 2013
Results First Submitted Date  ICMJE July 22, 2019
Results First Posted Date  ICMJE October 1, 2019
Last Update Posted Date February 19, 2020
Study Start Date  ICMJE March 2009
Actual Primary Completion Date September 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia. [ Time Frame: 6 and 12 months postoperatively ]
The care giver for each subject will be asked to complete SN-5 Pediatric sinonasal symptom survey (SN-5) at baseline (prior to surgery) and 6 and 12 months post surgery. The SN-5 is a health-related qualify of life (QOL) questionnaire which consists of 5 questions about sinus problems (sinus infection, nasal obstruction, allergy symptoms, emotional distress, activity limitations) each of which is scored by the caregiver on a 7 point response scale. The 5 responses are then averaged into an SN-5 overall score (1-7). 1 is the minimum value for the overall SN-5 (best QoL) and 7 is the maximum value (worst QoL) The questionnaire also asks the caregiver to grade overall health related quality of life using a visual analog scale from 0 (worse possible quality of life) to 10 (best possible quality of life). The visual analog scale is scored separately from the SN-5 average score.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2013)
Evaluate and compare quality of life outcomes between Adenoidectomy + Maxillary sinus irrigation with or without the use of balloon dilation or maxillary sinus ostia. [ Time Frame: 12-18 months post-operatively ]
Subjects will be seen 6 to 12 weeks, follow up will occur at 6, 12 and 18 months post-operativley. Subjects/care-givers will be asked to complete QofL (SN-5) at 6, 12 and 18 months.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
Official Title  ICMJE A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
Brief Summary Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease. Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of the throat) is performed since the adenoid pad may trap germs that enter a child's body and can get so swollen with bacteria that they become infected themselves. Functional endoscopic sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on children with this disease. Another treatment is adenoidectomy and irrigation of the maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon dilation of the maxillary sinus passage and irrigation experience improved quality of life outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with maxillary sinus irrigation without dilation of the sinus passage.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
Intervention  ICMJE
  • Device: Acclarent Relieva Balloon Sinuplasty

    A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.

    Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.

    Other Names:
    • Relieva Sinus Balloon Catheter 510K: K073041
    • Luma Illumination System 510K: K071845
    • Guide Cathetheter 510K: K043445
    • Votex Irrigation Catheter 510K: K043445
    • Guidewire 510K: K043445
    • Sidekick 510K: K043445
    • Inflation Devie 510K: K052198
  • Procedure: Adenoidectomy + Maxillary Sinus Irrigation

    A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.

    Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.

    After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home.

Study Arms  ICMJE
  • Active Comparator: Adenoidectomy without balloon dilation
    Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
    Intervention: Procedure: Adenoidectomy + Maxillary Sinus Irrigation
  • Experimental: Adenoidectomy with balloon dilation
    Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
    Intervention: Device: Acclarent Relieva Balloon Sinuplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2013)
48
Actual Study Completion Date  ICMJE September 29, 2016
Actual Primary Completion Date September 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
  2. Failure to respond to 3-week course of antibiotic and 3 month course of nasal steroid preparations or antihistamines as well as saline nasal irrigation
  3. Rhinosinusitis documented by CT scan following oral antibiotic course.

Computer tomographic findings considered to be consistent with sinusitis include partial or complete sinus opacification.

Allergy and immunology workup will be recommended on an individual basis -

Exclusion Criteria:

  1. Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
  2. History of facial trauma that distorts sinus anatomy
  3. Ciliary dysfunction
  4. Pregnancy will be excluded.
  5. Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
  6. Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
  7. Patients with a history of sinus surgery or significant anatomic abnormalities on CT scan that would require endoscopic sinus surgery or septoplasty would also be excluded.

Of note, children who will be undergoing concurrent surgeries will not be excluded.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01990820
Other Study ID Numbers  ICMJE EH09-177
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NorthShore University HealthSystem
Study Sponsor  ICMJE NorthShore University HealthSystem
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Gerber, MD NorthShore University HealthSystem
PRS Account NorthShore University HealthSystem
Verification Date February 2020

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