CompletedNot Applicable

Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients

Israel5 participantsStarted 2023-03-29

Plain-language summary

To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18
✓. Undergoing regular hemodialysis for ≥3 months
✓. Subject is capable of meeting study requirements including follow-up visit
✓. Subject completed 2-hour acclimatization session

Exclusion criteria

✕. Subject is enrolled to another clinical investigation that might interfere with this study
✕. Subject does not have any known skin problems (open or uncovered wounds, ulcers)
✕. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
✕. Scheduled living donor renal transplant during study participation
✕. Has resting pre-dialysis systolic blood pressure \<100mmHg
✕. Limb/s amputation
✕. Hyperkalemia \> 6meq/d"l

What they're measuring

Differences in weight gain over the long interdialytic period

Timeframe: Up to 50 days

Device related Adverse Events

Timeframe: Up to 60 Days

Trial details

NCT IDNCT06358365

SponsorAquaPass Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-02

View on ClinicalTrials.gov More Acute Kidney Failure trials