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Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain

NCT05598736 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-23

No results posted yet for this study

Summary

This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS) (NCT05562453). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.

Conditions

Interventions

DEVICE

FlowOx 2.0

-40mmHg intermittent negative pressure for 60 minutes per day

Sponsors & Collaborators

  • Otivio AS

    lead INDUSTRY

Principal Investigators

  • Kjell-Morten Myhr, MD, PhD · Dept. of Neurology Haukeland Univ. Hosp. & Dept. of Clin. Med, Univ. of Bergen, Norway

  • Peter Vestergaard Rasmussen, MD, PhD · Department of Clinical Medicine - The Department of Neurology, Aarhus University

  • Sara Haghighi Mobarhan Smith, MD, PhD · Linköping University, Linköping, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

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 NCT05598736 on ClinicalTrials.gov