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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02309307
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: Collplant
• Public title: Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow) CP-STR-01
• Scientific 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)
• Date of first enrolment: January 11, 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02309307
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Key inclusion & exclusion 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.

-



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non Ruptured Tendon Injuries

Tendinopathy

Intervention(s)

Device: Tissue Repair Device (VergenixTM STR)

Primary Outcome(s)

Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M. [Time Frame: Up to 194 days]

Health related Quality of life parameters questionnaire. [Time Frame: Up to 194 days]

Functional Disability using the PRTEE questionnaire. [Time Frame: Up to 194 days]

Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. [Time Frame: Up to 194 days]

Pain free/maximum grip strength (Dynamometer) [Time Frame: Up to 194 days]

Secondary ID(s)

CP-STR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors