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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing and able to give informed consent for participation in the study

• Adults aged over 18 years with a clinical diagnosis of orthostatic hypotension

• A drop in systolic BP of ≥20 mmHg (with or without a drop in diastolic BP ≥10 mmHg) within 3 minutes of standing up from a supine position

• Able to stand up from a supine position (with assistance if required)

Locations
Other Locations
United Kingdom
Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Neil Fawkes, MBChB DPM FFPM
neil@isotechltd.co.uk
+44 (0) 2830 835 500
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2024-03
Participants
Target number of participants: 30
Treatments
Experimental: Treatment
ISO-101 Device
Sponsors
Leads: Isotech Ltd
Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust

This content was sourced from clinicaltrials.gov