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

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

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

Study Overview

• Status: Completed
• Conditions: Long Head of Biceps Rupture
• Intervention / Treatment: Device: ST500 SINGLE-DOSE GEL

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Varese
    • Luino, Varese, Italy, 21016
      • Ospedale Luini Confalonieri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ST500 single-dose gel; The treatment is performed twice weekly for 6 weeks.	Device: ST500 SINGLE-DOSE GEL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of the ST500™ in supporting the physiological regenerative process of tendon	To evaluate the clinical performance of the ST500™ in supporting the physiological regenerative process of tendon assessed by high resolution ultrasound (HRUS)	10 weeks
Clinical performance of the ST500 in the attenuation of disability in patients affected by LHBT injury	To evaluate the clinical performance of the ST500 in the attenuation of disability in patients affected by Long Head of the Biceps Tendon (LHBT) injury assessed by range of motion through use of a digital goniometer.	10 weeks
Number of participants with Adverse Events (ST500 Safety and Tolerability)	To evaluate the tolerability and safety of ST500™ through identification of Adverse Events including assessment of the relationship of the Adverse Event to the Investigational Product (e.g. local allergic reaction).	10 weeks
Patient satisfaction of the ST500™	To evaluate the tolerability and patient satisfaction of the CR 500™ through a the completion of a specific questionnaire by the patient, the five-points Likert scale in which 1 means Strongly disagree with the assertion and 5 means Strongly agree	10 weeks

Collaborators and Investigators

• Sponsor: Contrad Swiss SA

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Peptides; Hyaluronic Acid; Long Head of Biceps; Long Head of Biceps Tendon Injury; LHBT injury; Constant-Murley Score
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Tendon Injuries
• Other Study ID Numbers: CTD-SW ST500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No