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Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication

NCT04100681 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-08-25

No results posted yet for this study

Summary

The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.

Conditions

  • Peripheral Vascular Disease
  • Intermittent Claudication
  • Walking, Difficulty
  • Critical Limb Ischemia
  • Ischemia Limb

Interventions

DEVICE

Active FlowOx™

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

DEVICE

Sham FlowOx™ (Placebo)

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

Sponsors & Collaborators

  • mediq Innovation Experts GmbH

    collaborator UNKNOWN

  • Hannover Medical School

    collaborator OTHER

  • Otivio AS

    lead INDUSTRY

Principal Investigators

  • Holger Lawall, Dr. Med · Gemeinschaftspraxis

  • Silke Zimmermann, Dr. rer.nat. · HCTC-KKS - Coordinating Center for Clinical Studies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2020-04-01
Completion
2020-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100681 on ClinicalTrials.gov