Nasal valve stenosis J34.2
Conditions
Interventions
Group 1: Nasal valve lift with Silhouette Soft
Sponsors
Sinclair Pharmaceuticals Ltd Eden House Lakeside
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age > 18 years - History: o Nasal obstruction o Insufficient treatment by local decongestants, steroids or by surgical procedures - Examination: o Nasal isthmus stenosis o Positive curette test o Positive Cottle Manoeuvre o Alar collapse while forced inspiration - Informed consent: Use of Silhouette Soft® threads for tissue restoration in the nasal valve area (nasal valve lift), technical procedure, complications, postoperative care - VAS = 4 assessed by patient
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women - History: o Previous surgery in the nasal valve area o Known adverse reactions to threads, fillers etc. o Allergies to implant or instrument materials o Autoimmunologic diseases, acute or chronic sinunasal infections o Other severe nose problems such as acute allergic symptoms, marked septal deviation or marked hyperplasia of the turbinates - Patients with limited ability or unwillingness to follow post-treatment recommendations - Nasal endoscopy o Marked septal deviation o Severe hyperplasia of the turbinates o Nasal tumours o Cicatricial valve stenosis o Nasal polyps - VAS 8 diagnosed by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the improvement in ease of nasal breathing at 6 months post treatment. The primary efficacy assessment will be made via a nasal obstruction score derived from a patient visual analogue scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints and respective assessment methods are: - Improvement of the nasal obstruction scores at 2-4 weeks, 12 months and 18 months post treatment via the patient VAS - Patient nasal questionnaire-based assessment of improvements in quality of life in areas impacted by ease of breathing such as, for example, smelling, sport activities, sleep quality, etc. - Safety: Assessment and recording of the adverse events via usual vigilance activities during the whole study. | — |
Countries
Germany
Contacts
Public ContactWerner Heppt
Städtisches Klinikum Karlsruhe Hals-Nasen-Ohrenklinik
Outcome results
None listed