Non Ruptured Tendon InjuriesCP-STR-01NCT02309307
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
A study testing Tissue Repair Device (VergenixTM STR) in people with Non Ruptured Tendon Injuries and Tendinopathy, run by Collplant at 3 sites in Israel.
Trial summary
The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Ruptured Tendon Injuries, Tendinopathy
- What is being tested?
- Tissue Repair Device (VergenixTM STR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesIsrael
- Study dates
- 11 Jan 2015to 24 Aug 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman aged 18 - 80 years old.
- Clinical diagnosis of lateral epicondylitis based on site of pain, pain
- elicited with active extension of the wrist in pronation and elbow
- extension.
- Documented ultrasonography diagnosis of common extensor
- tendinosis and possible tear based on abnormal echotexture (tendon
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- thickening, anechoic areas, areas of hypoechogencicity, loss of
- fibrillar pattern).
- Chronic symptoms (equal or greater than 3 months).
- PRTEE questionnaire score of at least 50 out of 100.
- For child-bearing potential females, documentation of birth
- control.
- Signing informed consent form. -
Who cannot join
- Acute symptom onset (less than 3 months).
- History of acute elbow trauma.
- History of Rheumatoid Arthritis.
- History of Inflammatory disease
- History of Fibromyalgia
- The patient has active malignant disease of any kind. A patient who
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- has had a malignant disease in the past, was treated and is currently
- disease-free for at least 5 years, may be considered for study entry.
- The patient is treated with anti-coagulant medication
- The patient previously underwent a surgery for lateral
- epicondylitis.
- The patient previously received local injections, including steroids
- within the last 30 days
- Signs of other causes for lateral elbow pain (posterior interosseous
- nerve entrapment, osteochondral lesion).
- Wounds around the elbow
- Likely problems, in the judgment of the investigator, with maintaining follow-up.
- Clinically significant abnormalities in hematology and blood
- chemistry lab tests at screening that in the opinion of the
- investigator might interfere with the patient's safety or participation
- in the study.
- Known as positive HIV, hepatitis B, or hepatitis C.
- Known history of a significant medical disorder, which in the
- investigator's judgment contraindicates the patient's participation.
- Known hypersensitivity and/or allergy to collagen.
- Drug or alcohol abuse (by history).
- Pregnancy of child-bearing potential females.
- Participation in another study within 30 days prior to screening
- visit.
- -
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Prospective, Open Label, Single Arm, Multi-center Study to Assess the Safety and Performance of a Soft Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).
Read the detailed description
The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.
- Conditions
- Non Ruptured Tendon Injuries, Tendinopathy
- Being tested
- Tissue Repair Device (VergenixTM STR)
- Keywords
- safety and performance
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Repair Device (VergenixTM STR)Device
Administration of Soft Tissue Repair Device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Tissue Repair Device | Experimental | Tissue Repair Device Receives: Device: Tissue Repair Device (VergenixTM STR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Measured: Up to 194 days
Functional Disability using the PRTEE questionnaire.
Measured: Up to 194 days
Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
Measured: Up to 194 days
Health related Quality of life parameters questionnaire.
Measured: Up to 194 days
Pain free/maximum grip strength (Dynamometer)
Measured: Up to 194 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study start11 Jan 2015
- Primary completion24 Aug 2016
- Study completion24 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Ruptured Tendon InjuriesStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collplant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309307
- Sponsor's protocol ID
- CP-STR-01
- Acronym
- CP-STR-01
- Status last verified
- Jan 2015
- First submitted
- 3 Dec 2014
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Single Arm, Multi-center Study to Assess the Safety and Performance of a Soft Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
- ClinicalTrials.gov ID
- NCT02309307
- Acronym / sponsor ID
- CP-STR-01 / CP-STR-01
- Conditions
- Non Ruptured Tendon Injuries, Tendinopathy
- Keywords
- safety and performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CollplantIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2015 (actual)
- Primary completion
- 24 Aug 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- 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.
The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).
Detailed description
The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Tissue Repair Device | Experimental | Device: Tissue Repair Device (VergenixTM STR)Tissue Repair Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Man or woman aged 18 - 80 years old.
- Clinical diagnosis of lateral epicondylitis based on site of pain, pain
- elicited with active extension of the wrist in pronation and elbow
- extension.
- Documented ultrasonography diagnosis of common extensor
Key exclusion criteria (30 listed)
- Acute symptom onset (less than 3 months).
- History of acute elbow trauma.
- History of Rheumatoid Arthritis.
- History of Inflammatory disease
- History of Fibromyalgia
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 |
|---|---|---|
| Tissue Repair Device (VergenixTM STR)Administration of Soft Tissue Repair Device | Device | Arm 1 Tissue Repair Device |
Primary outcome
Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Time frame: Up to 194 days
Functional Disability using the PRTEE questionnaire.
Time frame: Up to 194 days
Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
Time frame: Up to 194 days
Health related Quality of life parameters questionnaire.
Time frame: Up to 194 days
Pain free/maximum grip strength (Dynamometer)
Time frame: Up to 194 days
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 20 Feb 2019.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Repair Device (VergenixTM STR) in people with Non Ruptured Tendon Injuries and Tendinopathy, run by Collplant at 3 sites in Israel.
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 13 inclusion and 30 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. (time frame: Up to 194 days). The study lists 5 primary outcomes in all. 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 20 Feb 2019.