Status:
COMPLETED
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
Lead Sponsor:
Collplant
Conditions:
Non Ruptured Tendon Injuries
Tendinopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02309307
Start Date
January 11 2015
End Date
August 24 2016
Last Update
February 20 2019
Active Locations (3)
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1
Hadassah MC
Jerusalem, Israel
2
Meir MC
Kfar Saba, Israel
3
Assaf Harofeh MC
Zrifin, Israel