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

NCT02309307 | Completed

• 1 other identifier: CP-STR-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Non Ruptured Tendon Injuries; Tendinopathy

Keywords

safety and performance

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Arm 1 Tissue Repair Device

EXPERIMENTAL

Tissue Repair Device

Device: Tissue Repair Device (VergenixTM STR)

Interventions

Tissue Repair Device (VergenixTM STR) DEVICE

Administration of Soft Tissue Repair Device

Arm 1 Tissue Repair Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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).

Sponsors & Collaborators

• Collplant: lead

Study Sites (3)

Hadassah MC

Jerusalem, Israel

Location

Meir MC

Kfar Saba, Israel

Location

Assaf Harofeh MC

Zrifin, Israel

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: January 11, 2015
• Primary Completion: August 24, 2016
• Study Completion: August 24, 2016
• Last Updated: February 20, 2019

Record last verified: 2015-01

Locations

IL (3)