Silhouette Soft Performance in Improving Nasal Respiration - SuSPIre

Sinclair Pharmaceuticals Ltd Eden House Lakeside0 个研究点目标入组 56 人开始时间: 2020年12月11日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•- 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

发起方

Sinclair Pharmaceuticals Ltd Eden House Lakeside