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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03154541 |
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Date of registration:
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03/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SynRinse Irrigation Pilot (SIP) Trial
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Scientific title:
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SynRinse Irrigation Pilot (SIP) Trial |
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Date of first enrolment:
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June 6, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03154541 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Greg Davis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UW |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age >= 18
- Meet diagnostic criteria for CRS (as defined by the AAO-HNS 2015 Clinical Practice
Guidelines for Adult Sinusitis).
- Have undergone at least one functional endoscopic sinus surgery, be at least 6 weeks
out from surgery, be free of any complication from surgery, and have patent sinuses
confirmed by nasal endoscopy.
- Have active sinus disease as defined as purulent sinus discharge visualized on nasal
endoscopy.
- Have more than mild symptoms as determined by the SNOT-22 with a score >20.
- Be willing to hold off on standard therapy for chronic sinusitis for 1 week including
oral antibiotics and/or oral steroids.
- If on topical steroids for greater than 1 month (sprays, drops, or irrigation) these
will be continued based on the patients' current use (continued if they are already on
them, not initiated if they are not on them).
- Must be able to irrigate with large volume/low pressure nasal lavage throughout the
study.
Exclusion Criteria
:• Have an allergy to shell fish.
- Be able to return for follow up evaluation in 1 week (+ up to 5 days if needed)
- Have obstructive nasal polyps
- Participants who have used topical antibiotics within 4 weeks of treatment or are
actively using them and unwilling to stop
- Participants who have used systemic steroids within 4 weeks of treatment
- Are unable to give informed consent or complete self-administered questionnaires
written in English because of cognitive impairment, language barrier, or severe
medical conditions.
- Have a terminal illness or significant immune dysfunction.
- Have severe or emergent complications from CRS or presence of a sinus tumor.
- Patients with Cystic Fibrosis will be recruited in a parallel study.
- Participants who are unwilling to discontinue other sinus irrigations treatments and
steroid lavage if already on them (including baby shampoo, surfactant, colloid silver,
manuka honey, iodine, alcohol, tea tree oil, or any other compound).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis With Other Manifestations
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Sinusitis, Chronic
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Intervention(s)
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Drug: Synrinse
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Primary Outcome(s)
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Sino-Nasal Outcome Test 22 (SNOT-22)
[Time Frame: 1 week]
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Secondary Outcome(s)
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Visual Analog Scale (VAS)
[Time Frame: 1 week]
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Lund-Kennedy Endoscopy Score (LKES)
[Time Frame: 1 week]
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Future use questionnaire
[Time Frame: 1 week]
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Sinus bacteria culture
[Time Frame: 1 week]
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Secondary ID(s)
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STUDY00001280
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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