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

NCT ID: NCT02309307

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-11
• Study Completion Date: 2016-08-24

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 Tissue Repair Device

Tissue Repair Device

Group Type: EXPERIMENTAL

Tissue Repair Device (VergenixTM STR)

Intervention Type: DEVICE

Administration of Soft Tissue Repair Device

Interventions

Tissue Repair Device (VergenixTM STR)

Administration of Soft Tissue Repair Device

Intervention Type: DEVICE

Eligibility Criteria

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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Collplant

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah MC

Jerusalem, , Israel

Meir MC

Kfar Saba, , Israel

Assaf Harofeh MC

Zrifin, , Israel

Countries

Israel

Other Identifiers

CP-STR-01

Identifier Type: -

Identifier Source: org_study_id