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

Tendinopathy Clinical Trial

— CP-STR-01  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309307
• Other study ID #: CP-STR-01
• Status: Completed
• Phase: N/A
• Start date: January 11, 2015
• Est. completion date: August 24, 2016

Study information

• Verified date: January 2015
• Source: Collplant
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 24, 2016
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Man or woman aged 18 - 80 years old.

2. Clinical diagnosis of lateral epicondylitis based on site of pain, pain

elicited with active extension of the wrist in pronation and elbow

extension.

3. 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).

4. Chronic symptoms (equal or greater than 3 months).

5. PRTEE questionnaire score of at least 50 out of 100.

6. For child-bearing potential females, documentation of birth

control.

7. Signing informed consent form. -

Exclusion Criteria:

1. Acute symptom onset (less than 3 months).

2. History of acute elbow trauma.

3. History of Rheumatoid Arthritis.

4. History of Inflammatory disease

5. History of Fibromyalgia

6. 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.

7. The patient is treated with anti-coagulant medication

8. The patient previously underwent a surgery for lateral

epicondylitis.

9. The patient previously received local injections, including steroids

within the last 30 days

10. Signs of other causes for lateral elbow pain (posterior interosseous

nerve entrapment, osteochondral lesion).

11. Wounds around the elbow

12. Likely problems, in the judgment of the investigator, with maintaining follow-up.

13. 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.

14. Known as positive HIV, hepatitis B, or hepatitis C.

15. Known history of a significant medical disorder, which in the

investigator's judgment contraindicates the patient's participation.

16. Known hypersensitivity and/or allergy to collagen.

17. Drug or alcohol abuse (by history).

18. Pregnancy of child-bearing potential females.

19. Participation in another study within 30 days prior to screening

visit.

Related Conditions & MeSH terms

• Non Ruptured Tendon Injuries
• Tendinopathy
• Tendon Injuries
• Tennis Elbow

Intervention

Device:
• Tissue Repair Device (VergenixTM STR)
Administration of Soft Tissue Repair Device

Locations

Country	Name	City	State
Israel	Hadassah MC	Jerusalem
Israel	Meir MC	Kfar Saba
Israel	Assaf Harofeh MC	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Collplant

Country where clinical trial is conducted

Israel, 

Outcome

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