SynRinse Irrigation Pilot (SIP) Trial (NCT03154541) | Clinical Trial Compass
CompletedPhase 1/2
SynRinse Irrigation Pilot (SIP) Trial
United States30 participantsStarted 2017-06-06
Plain-language summary
Assess if the use of SYNRINSE can improve short-term subjective and objective outcome measures after one week in patients with active Chronic Rhinosinusitis (CRS) who have had prior sinus surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.