Evaluation of the Effect on Functionality of the "ST500 SINGLE- DOSE GEL" Medical Device in Patients With Symptomatic Long Head of the Biceps Tendon Injury: a Postmarket Interventional, Single Arm Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Clinical performance of the ST500™ in the increase of shoulder functionality, in terms of difference (percent) in the Constant-Murley Score (CMS) between the end of study visit and baseline visit.
研究概览
简要总结
Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device
详细描述
The aim of this single arm, post-market, confirmatory, interventional clinical investigation was to evaluate the effect on shoulder functionality and symptoms in patients affected by LHBT injury of a HA-based gel containing a peptide mixture, the ST500 SINGLE-DOSE GEL (ST500TM), topically applied to the shoulder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged ≥18 years at the time of the signature of ICF.
- •Unilateral or bilateral LHBT injury of mild or moderate severity (CMS ≤ 70).
- •Willing to follow all study procedures, including attending all site visits, tests and examinations.
- •Willing to participate in the study and sign the ICF.
排除标准
- •Other - different - clinical conditions of the shoulder requiring surgical intervention as well as full rotator cuff tears and LHBT lesions classified as Type IV, V, or VI.
- •Previous shoulder(s) surgery.
- •Infective or inflammatory processes near the area of treatment.
- •Damaged skin in the area of treatment.
- •Ongoing cutaneous allergies.
- •Serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
- •Allergy to device components (Sodium hyaluronate; SH-Polypeptide-29; SH-Tripeptide-1; Demineralized water; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
- •Any other systemic or local therapy for the treatment of LHBT injury (only physiotherapy is allowed).
- •Any other systemic or local therapy (e.g. corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of LHBT injury under treatment with the medical device ST500 (only the use of paracetamol, according the procedures described in the protocol, is allowed to treat the painful state related to LHBT injury).
- •High consumption of analgesic drugs for the painful state upon clinician judgement (i.e., NSAIDs + opioid or NSAIDs + steroids).
- •Immune system illnesses.
- •Uncontrolled systemic diseases.
- •Known drug and/or alcohol abuse.
- •Mental incapacity that precludes adequate understanding or cooperation.
- •Participation in another investigational study.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Clinical performance of the ST500™ in the increase of shoulder functionality, in terms of difference (percent) in the Constant-Murley Score (CMS) between the end of study visit and baseline visit.
时间窗: 10 weeks
To evaluate the clinical performance of the ST500™ in the increase of shoulder functionality, in terms of difference (percent) in the Constant-Murley Score (CMS) between the end of study visit and baseline visit, in patients affected by Long Head of the Biceps Tendon (LHBT) injury. The Constant-Murley score (CMS) is a 100-points scale, that ranges from 0 points (most disability) to 100 points (least disability).
次要结局
- Clinical performance of the ST500™ in supporting the physiological regenerative process of tendon(10 weeks)
- Clinical performance of the ST500 in the attenuation of disability in patients affected by LHBT injury(10 weeks)
- Patient satisfaction of the ST500™(10 weeks)
- Number of participants with Adverse Events (ST500 Safety and Tolerability)(10 weeks)