Long Head of Biceps RuptureNCT05785520
Evaluation of the "ST500 SINGLE- DOSE GEL" in Patients With Symptomatic Long Head of the Biceps Tendon Injury
A study testing ST500 SINGLE-DOSE GEL in people with Long Head of Biceps Rupture, run by Contrad Swiss SA at 1 site in Italy.
Trial summary
Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Head of Biceps Rupture
- What is being tested?
- ST500 SINGLE-DOSE GEL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2021to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Single arm, post-market, confirmatory, interventional clinical investigation - Medical Device
Read the 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.
- Conditions
- Long Head of Biceps Rupture
- Being tested
- ST500 SINGLE-DOSE GEL
- Keywords
- Long Head of Biceps, Long Head of Biceps Tendon Injury, Hyaluronic Acid, Peptides, LHBT injury, Constant-Murley Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST500 SINGLE-DOSE GELDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ST500 single-dose gel | Other | The treatment is performed twice weekly for 6 weeks. Receives: Device: ST500 SINGLE-DOSE GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 weeks
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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).
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start30 Nov 2021
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Head of Biceps RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contrad Swiss SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785520
- Sponsor's protocol ID
- CTD-SW ST500
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05785520
- Acronym / sponsor ID
- CTD-SW ST500
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Contrad Swiss SAIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST500 single-dose gel | Other | Device: ST500 SINGLE-DOSE GELThe treatment is performed twice weekly for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST500 SINGLE-DOSE GELST500 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. | Device | ST500 single-dose gel |
Primary outcome
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.
Time frame: 10 weeks
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).
4 secondary outcomes
Clinical performance of the ST500™ in supporting the physiological regenerative process of tendon
Time frame: 10 weeks
Clinical performance of the ST500 in the attenuation of disability in patients affected by LHBT injury
Time frame: 10 weeks
Number of participants with Adverse Events (ST500 Safety and Tolerability)
Time frame: 10 weeks
Patient satisfaction of the ST500™
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ST500 SINGLE-DOSE GEL in people with Long Head of Biceps Rupture, run by Contrad Swiss SA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.