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

Primary Purpose

Long Head of Biceps Rupture

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ST500 SINGLE-DOSE GEL
Sponsored by
Contrad Swiss SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long Head of Biceps Rupture focused on measuring Long Head of Biceps, Long Head of Biceps Tendon Injury, Hyaluronic Acid, Peptides, LHBT injury, Constant-Murley Score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or breastfeeding.

Sites / Locations

  • Ospedale Luini Confalonieri

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ST500 single-dose gel

Arm Description

The treatment is performed twice weekly for 6 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.
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).
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

Full Information

First Posted
February 21, 2023
Last Updated
March 14, 2023
Sponsor
Contrad Swiss SA
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1. Study Identification

Unique Protocol Identification Number
NCT05785520
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contrad Swiss SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Head of Biceps Rupture
Keywords
Long Head of Biceps, Long Head of Biceps Tendon Injury, Hyaluronic Acid, Peptides, LHBT injury, Constant-Murley Score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ST500 single-dose gel
Arm Type
Other
Arm Description
The treatment is performed twice weekly for 6 weeks.
Intervention Type
Device
Intervention Name(s)
ST500 SINGLE-DOSE GEL
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Clinical performance of the ST500™ in supporting the physiological regenerative process of tendon
Description
To evaluate the clinical performance of the ST500™ in supporting the physiological regenerative process of tendon assessed by high resolution ultrasound (HRUS)
Time Frame
10 weeks
Title
Clinical performance of the ST500 in the attenuation of disability in patients affected by LHBT injury
Description
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.
Time Frame
10 weeks
Title
Number of participants with Adverse Events (ST500 Safety and Tolerability)
Description
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).
Time Frame
10 weeks
Title
Patient satisfaction of the ST500™
Description
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
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or breastfeeding.
Facility Information:
Facility Name
Ospedale Luini Confalonieri
City
Luino
State/Province
Varese
ZIP/Postal Code
21016
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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