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Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST500 single-dose gel | Other | The treatment is performed twice weekly for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Luini Confalonieri | Luino | Varese | 21016 | Italy |
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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 |