Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons (NCT02509663) | Clinical Trial Compass
TerminatedNot Applicable
Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons
Stopped: the manufacturer of the device has been bought and the new company does not want to continue the study anymore
France9 participantsStarted 2018-06-15
Plain-language summary
The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain, ensure faster return to daily life activities (reduction of the average length of hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and reduction of post-operative pain score seams decrease on EVA.
The economic impact of the sinuplasty balloon appears very favourable and fits into the strategy of development of the ambulatory practice.
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:
* Man or woman of age ≥ to 18 years.
* Patient for which a frontal sinus surgery (Draf 1 type) is programmed for any type of frontal sinusitis unresponsive to drug treatment properly leads.
* Patient affiliated to a social protection scheme Written informed consent of the patient
* Signed informed consent
Exclusion Criteria:
* Polyposis sinonasal or other sinus to be the subject of a simultaneous complementary intervention
* Sinuso-nasal tumors
* Osteogenesis
* Fragile patients or patient needing gesture contraindicating surgery by rigid instrumentation
* Contraindication with balloon using
* Contraindication to general anesthesia
* Immunosuppressive therapy
* Patient under judicial protection
* Pregnancy or Breastfeeding
* Exclusion period determinated with concurrent participation in other experimental studies
* Contrast medium allergy background
* Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)
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
Cost-utility ratio
Timeframe: This ratio will be assessed for 12 months post surgery