Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

A multi-center, randomized, sham (placebo)-controlled, double-blind trial to assess the efficacy and safety of FlowOx. This is done by comparing the increase in pain free walking distance compared to sham (placebo) device in patients with peripheral arterial disease (PAD) and intermittent claudication.

This study is conducted to assess the efficacy and safety of FlowOx™ compared to a sham FlowOx™ (placebo) device treatment. FlowOx™ can provide intermittent negative pressure (up to - 40 mmHg INP [intermittent negative pressure]) which is known to improve blood flow. The same device will also work as a sham (placebo) device by less negative pressure exerted by the device (in the range of -10 mmHg).

Daily home use of FlowOx™ for 2 hours (divided into minimum two sessions of 1 hour) per day in PAD-patients with intermittent claudication (stage II acc.to EMA, equivalent to Fontaine stage IIb in Germany) relative to sham (placebo) will be provided over a period of 12 weeks.

This efficacy study is evaluating the clinical effects of INP on patient with intermittent claudication with special focus on changes in pain free walking distance and quality of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04100681
Study type Interventional
Source Otivio AS
Contact
Status Terminated
Phase N/A
Start date August 19, 2019
Completion date May 31, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03668353 - Recombinant SeV-hFGF2/dF Injection for PAOD Phase 1
Recruiting NCT04110964 - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT Phase 1
Not yet recruiting NCT03994666 - Cell Therapy in Critical Limb Ischemia Phase 2
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Not yet recruiting NCT02498080 - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia N/A
Recruiting NCT02239419 - Evaluation of Carbothera in the Treatment of Foot Ulcers N/A
Recruiting NCT01938872 - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia N/A
Active, not recruiting NCT01211925 - Distal Venous Arterialisation of Ischemic Limb Phase 2/Phase 3
Completed NCT02454231 - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Phase 2/Phase 3
Completed NCT01758874 - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Phase 2
Completed NCT02475200 - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting NCT04583436 - Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia N/A
Completed NCT04071782 - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore N/A
Completed NCT03669458 - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. N/A
Not yet recruiting NCT06007469 - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting NCT04110327 - An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed NCT02260622 - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia Phase 2
Recruiting NCT02054416 - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality N/A