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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Contrad Swiss SA
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
ST500 single-dose gel
The treatment is performed twice weekly for 6 weeks.
Intervention: ST500 SINGLE-DOSE GEL (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 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).
Secondary Outcomes
- 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)