Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)

Study Overview
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Brief Summary
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The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).

Detailed Description
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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.

Official Title
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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)

Conditions
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Non Ruptured Tendon Injuries, Tendinopathy

Intervention / Treatment
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* Device: Tissue Repair Device (VergenixTM STR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. - Exclusion Criteria: 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 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Tissue Repair Device<br>Tissue Repair Device | Device: Tissue Repair Device (VergenixTM STR)<br>* Administration of Soft Tissue Repair Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. |  | Up to 194 days | 
| Functional Disability using the PRTEE questionnaire. |  | Up to 194 days | 
| Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M. |  | Up to 194 days | 
| Health related Quality of life parameters questionnaire. |  | Up to 194 days | 
| Pain free/maximum grip strength (Dynamometer) |  | Up to 194 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety and performance