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

NCT05785520 | Completed DMC

• 1 other identifier: CTD-SW ST500
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  10 weeks

Secondary Outcomes (4)

• 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

• Number of participants with Adverse Events (ST500 Safety and Tolerability)

  10 weeks

• Patient satisfaction of the ST500™

  10 weeks

Study Arms (1)

ST500 single-dose gel

OTHER

The treatment is performed twice weekly for 6 weeks.

Device: ST500 SINGLE-DOSE GEL

Interventions

ST500 SINGLE-DOSE GEL DEVICE

ST500 SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, useful to limit the physiological degeneration of the joints and tissues, improving their functionality. The presence of a peptide mixture and sodium hyaluronate facilitates the movement of joints and tendons for greater mobility and flexibility.

ST500 single-dose gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contrad Swiss SA: lead

Study Sites (1)

Ospedale Luini Confalonieri

Luino, Varese, 21016, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 27, 2023
• Study Start: November 30, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-02

Locations

IT (1)