Clinical trial NCT05785520: Evaluation of the "ST500 SINGLE- DOSE GEL" in Patients With Symptomatic Long Head of the Biceps Tendon Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Head of Biceps Rupture
Keywords: Long Head of Biceps
Long Head of Biceps Tendon Injury
Hyaluronic Acid
Peptides
LHBT injury
Constant-Murley Score
Lead sponsor: Contrad Swiss SA
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 10 weeks
Secondary outcomes:
measure: Clinical performance of the ST500™ in supporting the physiological regenerative process of tendon
timeFrame: 10 weeks
measure: Clinical performance of the ST500 in the attenuation of disability in patients affected by LHBT injury
timeFrame: 10 weeks
measure: Number of participants with Adverse Events (ST500 Safety and Tolerability)
timeFrame: 10 weeks
measure: Patient satisfaction of the ST500™
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Luino
country: Italy
facility: Ospedale Luini Confalonieri
state: Varese
Study officials:
References: