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

Primary Purpose

Non Ruptured Tendon Injuries, Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tissue Repair Device (VergenixTM STR)
Sponsored by
Collplant
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Ruptured Tendon Injuries focused on measuring safety and performance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Hadassah MC
  • Meir MC
  • Assaf Harofeh MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1 Tissue Repair Device

Arm Description

Tissue Repair Device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
February 19, 2019
Sponsor
Collplant
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1. Study Identification

Unique Protocol Identification Number
NCT02309307
Brief Title
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 11, 2015 (Actual)
Primary Completion Date
August 24, 2016 (Actual)
Study Completion Date
August 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collplant

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Ruptured Tendon Injuries, Tendinopathy
Keywords
safety and performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Tissue Repair Device
Arm Type
Experimental
Arm Description
Tissue Repair Device
Intervention Type
Device
Intervention Name(s)
Tissue Repair Device (VergenixTM STR)
Intervention Description
Administration of Soft Tissue Repair Device
Primary Outcome Measure Information:
Title
Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Time Frame
Up to 194 days
Title
Functional Disability using the PRTEE questionnaire.
Time Frame
Up to 194 days
Title
Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
Time Frame
Up to 194 days
Title
Health related Quality of life parameters questionnaire.
Time Frame
Up to 194 days
Title
Pain free/maximum grip strength (Dynamometer)
Time Frame
Up to 194 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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. -
Facility Information:
Facility Name
Hadassah MC
City
Jerusalem
Country
Israel
Facility Name
Meir MC
City
Kfar Saba
Country
Israel
Facility Name
Assaf Harofeh MC
City
Zrifin
Country
Israel

12. IPD Sharing Statement

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

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