Trials / Unknown
UnknownNCT06039410
A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Isotech Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-15
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
- First posted
- 2023-09-15
- Last updated
- 2024-02-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06039410. Inclusion in this directory is not an endorsement.