Rhinitis + Sinusitis, Pediatric Chronic RhinosinusitisNCT01990820
Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
A study testing Acclarent Relieva Balloon Sinuplasty and Adenoidectomy + Maxillary Sinus Irrigation in people with Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
- What is being tested?
- Acclarent Relieva Balloon Sinuplasty and Adenoidectomy + Maxillary Sinus Irrigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 29 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
- 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
- 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 -
Who cannot join
- Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
- History of facial trauma that distorts sinus anatomy
- Ciliary dysfunction
- Pregnancy will be excluded.
- Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
- Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
Show all 9Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
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.
- Being tested
- Acclarent Relieva Balloon Sinuplasty, Adenoidectomy + Maxillary Sinus Irrigation
- Keywords
- Pediatric Chronic Rhinosinusitis
- Medical subject headings
- Rhinitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acclarent Relieva Balloon SinuplastyDevice
Also called Relieva Sinus Balloon Catheter 510K: K073041, Luma Illumination System 510K: K071845, Guide Cathetheter 510K: K043445, Votex Irrigation Catheter 510K: K043445
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.
Adenoidectomy + Maxillary Sinus IrrigationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Adenoidectomy without balloon dilation | Active comparator | Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. Receives: Procedure: Adenoidectomy + Maxillary Sinus Irrigation |
| Adenoidectomy with balloon dilation | Experimental | Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation Receives: Device: Acclarent Relieva Balloon Sinuplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.
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.
Measured: 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMar 2009
- Primary completion29 Sep 2016
- Study completion29 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis + Sinusitis, Pediatric Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Gerber, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990820
- Sponsor's protocol ID
- EH09-177
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2013
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
- ClinicalTrials.gov ID
- NCT01990820
- Acronym / sponsor ID
- EH09-177
- Keywords
- Pediatric Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenoidectomy without balloon dilation | Active comparator | Procedure: Adenoidectomy + Maxillary Sinus IrrigationSubjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. |
| Adenoidectomy with balloon dilation | Experimental | Device: Acclarent Relieva Balloon SinuplastyAdenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
- 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
- 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 -
Key exclusion criteria (9 listed)
- Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
- History of facial trauma that distorts sinus anatomy
- Ciliary dysfunction
- Pregnancy will be excluded.
- Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acclarent Relieva Balloon SinuplastyAlso: Relieva Sinus Balloon Catheter 510K: K073041, Luma Illumination System 510K: K071845, Guide Cathetheter 510K: K043445, Votex Irrigation Catheter 510K: K043445A 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. | Device | Adenoidectomy with balloon dilation |
| Adenoidectomy + Maxillary Sinus IrrigationA 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. | Procedure or surgery | Adenoidectomy without balloon dilation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gerber, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acclarent Relieva Balloon Sinuplasty and Adenoidectomy + Maxillary Sinus Irrigation in people with Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.