Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow) (CP-STR-01)

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)

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

Study Overview

• Status: Completed
• Conditions: Tendinopathy; Non Ruptured Tendon Injuries
• Intervention / Treatment: Device: Tissue Repair Device (VergenixTM STR)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah MC
  • Kfar Saba, Israel
    • Meir MC
  • Zrifin, Israel
    • Assaf Harofeh Mc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Tissue Repair Device; Tissue Repair Device	Device: Tissue Repair Device (VergenixTM STR); Administration of Soft Tissue Repair Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Collplant

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2015
• Primary Completion (Actual): August 24, 2016
• Study Completion (Actual): August 24, 2016

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: safety and performance
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Arm Injuries; Elbow Tendinopathy; Tendinopathy; Tennis Elbow; Tendon Injuries
• Other Study ID Numbers: CP-STR-01