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Transdermal Fluid Removal in Fluid Overload

NCT03959930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-06-01

No results posted yet for this study

Summary

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Conditions

Interventions

DEVICE

Transdermal Fluid Removal

The Transdermal Fluid Removal (TFR) device is designed for use on the lower limbs of patients with Chronic Heart Failure and treatment resistant peripheral oedema. The TFR device is intended to be applied on oedematous skin of eligible patients, for periods of up to 10 hours at a time, to gently remove excess fluid through the skin, over a period of a few days during exacerbations, thereby avoiding hospitalisation for intravenous diuretics. The TFR device is designed to be used in conjunction with standard Negative Pressure Wound Therapy (NPWT) devices which are currently CE Marked and approved for use in both acute and homecare environment.

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-03-14
Completion
2022-03-14

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT03959930 on ClinicalTrials.gov