Evaluation of the "ST500 SINGLE- DOSE GEL" in Patients With Symptomatic Long Head of the Biceps Tendon Injury

Contrad Swiss

Status: Completed

Conditions: Long Head of Biceps Rupture

Treatments: Device: ST500 SINGLE-DOSE GEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05785520

CTD-SW ST500

Details and patient eligibility

About

Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female, aged ≥18 years at the time of the signature of ICF.
2. Unilateral or bilateral LHBT injury of mild or moderate severity (CMS ≤ 70).
3. Willing to follow all study procedures, including attending all site visits, tests and examinations.
4. Willing to participate in the study and sign the ICF.

Exclusion criteria

1. 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.
2. Previous shoulder(s) surgery.
3. Infective or inflammatory processes near the area of treatment.
4. Damaged skin in the area of treatment.
5. Ongoing cutaneous allergies.
6. Serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
7. 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).
8. Any other systemic or local therapy for the treatment of LHBT injury (only physiotherapy is allowed).
9. 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).
10. High consumption of analgesic drugs for the painful state upon clinician judgement (i.e., NSAIDs + opioid or NSAIDs + steroids).
11. Immune system illnesses.
12. Uncontrolled systemic diseases.
13. Known drug and/or alcohol abuse.
14. Mental incapacity that precludes adequate understanding or cooperation.
15. Participation in another investigational study.
16. Pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

ST500 single-dose gel

Other group

Description:

The treatment is performed twice weekly for 6 weeks.

Treatment:

Device: ST500 SINGLE-DOSE GEL