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A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.

Orthostatic Hypotension Clinical Trial

Official title:
ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study

Clinical Trial Summary

The goal of this clinical trial is to test a novel medical device (ISO-101) in patients diagnosied with orthostatic hypotension. The main question[s] it aims to answer are: - to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation. - Assess the safety and performance of the ISO-101 device in patients with orthostatic hypotension. Participants will use the device under controlled conditions and have the following parameters measured before and after standing up: - blood pressure - markers of peripheal vascular resistence - sympathetic nervous system activity measure before and after standing up

Clinical Trial Description

This is a proof of principle study aimed at evaluating if there is a signal of efficacy from use of the ISO-101 device in people with orthostatic hypotension. The study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.The primary objective is to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06039410
Study type Interventional
Source Isotech Ltd
Contact Neil Fawkes, MBChB DPM FFPM
Phone +44 (0) 2830 835 500
Email neil@isotechltd.co.uk
Status Recruiting
Phase N/A
Start date December 15, 2023
Completion date March 2024
View Details
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