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

NCT06039410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-22

No results posted yet for this study

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

Conditions

  • Orthostatic Hypotension

Interventions

DEVICE

ISO-101

ISO-101 is an experimental wearable class 1 medical device which when used is able to raise the blood pressure upon standing via controlled isometric muscular contractions

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • Isotech Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • United Kingdom

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 NCT06039410 on ClinicalTrials.gov