Evaluation of Cirvo™ Mobile Compression Device for Treatm... | NCT03544788

Studies
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers

NCT03544788

Sponsor

Radial Medical, Inc.

Status

Withdrawn

Last Update Posted

Sep 11, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Venous Leg Ulcer

Interventions

Cirvo™ Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision

Expanded Access Info

Start Date

Jun 30, 2019Estimated

Primary Completion Date

Feb 1, 2020Estimated

Completion Date

Feb 1, 2020Estimated

First Submitted Date

May 21, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cirvo™ Therapy	Experimental		Device: Cirvo™ Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cirvo™ Therapy	Device	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of subjects fully healed at 12 weeks		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent of wound epithelialized at 12 weeks		12 weeks
Percent of subjects fully healed at 4 weeks		4 weeks

Other Outcomes

Measure	Description	Time Frame
Time to complete healing in fully-healed subjects		12 weeks
Therapy-related adverse events will be collected throughout the 12-week study period		12 weeks
Characterization of Quality of Life measured using the EQ-5D-5L

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients between 18 and 80 years of age
Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
Total venous ulcer area < 20cm2
Duration of therapy for active venous ulcer <26 weeks prior to enrollment
Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system

Exclusion Criteria:

Acute DVT within the 3 months prior to enrollment
Ulcer present for <2 weeks
Ulcers extending with exposed fascia, tendon, or bone within the wound margins
Lateral malleolus ulcers
Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
Active infection (systemic or in the affected limb)
Lower extremity gangrene
Diabetes mellitus (Type I or II) requiring medication
History of pulmonary vascular disease (PVD)
History of pulmonary edema
History of decompensated congestive heart failure (CHF)
Open surgery or major trauma to the legs within the last six months
History of lower limb malignancy, primary or secondary
Acute symptomatic lower extremity thrombophlebitis
Pregnant or breastfeeding
Calf geometry on which Cirvo(TM) device does not appropriately fit
Known sensitivity to any of the materials used in the Cirvo(TM) device
Currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer