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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by NorthShore University HealthSystem Research Institute.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
NorthShore University HealthSystem
Information provided by (Responsible Party):
Mark Gerber, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01990820
First received: November 16, 2013
Last updated: February 11, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
Device: Acclarent Relieva Balloon Sinuplasty
Procedure: Adenoidectomy + Maxillary Sinus Irrigation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Quality of life (QoL) 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-operatively. Subjects/care-givers will be asked to complete QofL (SN-5) at 6, 12 and 18 months.


Estimated Enrollment: 48
Study Start Date: March 2009
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
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.

Experimental: Arm 2
Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990820

Contacts
Contact: Mira Shiloach, MS CCRP (847) 657-1750 mshiloach@northshore.org
Contact: K. Agnes Brugger, RN BSN (847) 570-1632 kbrugger@northshore.org

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Mira Shiloach, MS CCRP    847-657-1750    mshiloach@northshore.org   
Contact: K. Agnes Brugger, RN BSN    (847) 570-1632    kbrugger@northshore.org   
Principal Investigator: Mark Gerber, MD         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
NorthShore University HealthSystem
Investigators
Principal Investigator: Mark Gerber, MD NorthShore University HealthSystem
  More Information

Responsible Party: Mark Gerber, MD, Director, Pediatric Otolaryngology-Head and Neck Surgery; Division Head, Otolaryngology-Head and Neck Surgery, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01990820     History of Changes
Other Study ID Numbers: EH09-177
Study First Received: November 16, 2013
Last Updated: February 11, 2015

Keywords provided by NorthShore University HealthSystem Research Institute:
Pediatric Chronic Rhinosinusitis

Additional relevant MeSH terms:
Rhinitis
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Oxymetazoline
Phenylephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2017