Silhouette Soft Performance in Improving Nasal Respiratio

Not Applicable

• Conditions: asal valve stenosis; J34.2; Deviated nasal septum

• Registration Number: DRKS00023291
• Lead Sponsor: Sinclair Pharmaceuticals Ltd Eden House Lakeside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-11
• Study Completion: 2023-06-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

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

- 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 < 4 or > 8 diagnosed by physician

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the improvement in ease of nasal breathing at 6 months post treatment.<br>The primary efficacy assessment will be made via a nasal obstruction score derived from a patient visual analogue scale (VAS).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints and respective assessment methods are:<br>- Improvement of the nasal obstruction scores at 2-4 weeks, 12 months and 18 months post treatment via the patient VAS<br>- 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.<br>- Safety: Assessment and recording of the adverse events via usual vigilance activities during the whole study.