CompletedNot Applicable

Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients

Israel25 participantsStarted 2020-01-28

Plain-language summary

The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18
✓. Subject has been informed on the nature of the study and has provided informed consent
✓. Subject is capable of meeting study requirements
✓. Age ≥ 18 and diagnosed with CHF
✓. Subject has 2 or more score for pitting edema
✓. Subject is taking diuretic medications at home
✓. Subject has been informed on the nature of the study and has provided informed consent
✓. Subject is capable of meeting study requirements

Exclusion criteria

✕. Subject is enrolled to another clinical investigation that might interfere with this study
✕. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
✕. Subject has no known sensitivity to Neoprene
✕. Subject is enrolled to another clinical investigation that might interfere with this study
✕. Subject is admitted to the hospital for acute decompensated or acute heart failure
✕. Subject has any known lower body skin problems (open wounds, ulcers)
✕. eGFR\<15 ml/min/m2
✕. Subject with severe peripheral arterial disease

What they're measuring

Safety Events

Timeframe: 30 days

System Activation

Timeframe: During procedure

Treatment Toleration

Timeframe: During procedure

Trial details

NCT IDNCT04578353

SponsorAquaPass Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-12

View on ClinicalTrials.gov More Chronic Heart Failure trials