Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow) (CP-STR-01)
Non Ruptured Tendon Injuries, Tendinopathy
About this trial
This is an interventional treatment trial for Non Ruptured Tendon Injuries focused on measuring safety and performance
Eligibility Criteria
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.
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Sites / Locations
- Hadassah MC
- Meir MC
- Assaf Harofeh MC
Arms of the Study
Arm 1
Experimental
Arm 1 Tissue Repair Device
Tissue Repair Device