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Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain
Sponsor: Otivio AS
Summary
The study is 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). 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, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.
Official title: A Double-blind, Randomized, Controlled, Parallel Design 4-week Investigation, Followed by an Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2022-10-04
Completion Date
2024-01-02
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
FlowOx 2.0
Subjects randomized to tretament with the investigational device will receive treatment with -40 mmHg intermittent negative pressure for 60 minutes per day.
FlowOx2.0 (Sham)
Subjects randomized to treatment with the comparator will receive treatment with -10 mmHg intermittent negative pressure for 60 minutes per day.
Locations (1)
NeuroCentrum (Centrum för Neurologi)
Stockholm, Stockholm County, Sweden