RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectom… (NCT02559284) | Clinical Trial Compass
CompletedNot Applicable
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
France189 participantsStarted 2015-04
Plain-language summary
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.
Who can participate
Age range
18 Years – 65 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:
* Males or females between 18 and 65 years of age
* Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:
* Sinonasal polyposis alone
* Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs
* Free and informed written consent
* Member or beneficiary of a social security program
Exclusion Criteria:
* Oral corticosteroid treatment since less than 2 months
* Premenopausal women not using effective contraception (oral or intrauterine device)
* Pregnant or nursing women
* Uncontrolled diabetes (not treated or stabilized by treatment)
* HIV-positive status
* Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology)
* All contraindication of RESPIMER® NetiFlow®
* All diseases resulting in difficulty coughing or swallowing
* Ongoing or past radiation treatment to the head and neck
* Ongoing or recent chemotherapy (within a three-month period)
* Subjects using anticoagulants
* Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study
* Subjects placed under judicial protection
* Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the…
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.
What they're measuring
1
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Timeframe: D14 meaning 14 days (plus or minus 3 days) after surgery