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Terminated NCT02509663

Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons

Conditions: Frontal Sinusitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 9
Sponsor: University Hospital, Strasbourg, France

Location: Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin Bordeaux

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.

Eligibility Criteria

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...)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02509663). StuddyBuddy aggregates publicly available trial information.