Trials / Completed
CompletedNCT02309307
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Collplant · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tissue Repair Device (VergenixTM STR) | Administration of Soft Tissue Repair Device |
Timeline
- Start date
- 2015-01-11
- Primary completion
- 2016-08-24
- Completion
- 2016-08-24
- First posted
- 2014-12-05
- Last updated
- 2019-02-20
Locations
3 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02309307. Inclusion in this directory is not an endorsement.