Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
NCT03544788 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-09-11
Summary
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
Conditions
- Venous Leg Ulcer
Interventions
- DEVICE
-
Cirvo™ Therapy
The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression for the treatment of venous leg ulcers (VLU).
Sponsors & Collaborators
-
Radial Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-30
- Primary Completion
- 2020-02-01
- Completion
- 2020-02-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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