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

NCT06358365 | Completed

• 1 other identifier: AQP-DCL-026
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Failure; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Differences in weight gain over the long interdialytic period

  weight at the end of the last Hemodialysis session before AquaPass therapy subtracted from the weight in the morning of the first Hemodialysis session of the week after AquaPass therapy.

  Up to 50 days

• Device related Adverse Events

  Safety evaluation of device-related adverse effects

  Up to 60 Days

Secondary Outcomes (4)

• Changes in NT-proBNP

  Up to 50 days

• Changes in Blood Urea Nitrogen

  Up to 50 days

• Effect on Quality of Life

  up to 50 days

• Affect on Ultrafiltration Rates after the long inter dialytic gap

  up to 28 days

Study Arms (1)

adult patients undergoing regular hemodialysis

EXPERIMENTAL

This study will be a crossover study with one center and an open label design. Patients who sign the informed consent form and meet the inclusion and exclusion criteria will undergo a 2-hour acclimatization period to verify their ability to adhere to the AquaPass procedure. Once enrolled, patients will undergo a 3-week observation period where they will continue with their regular hemodialysis treatment with no changes. Study endpoint parameters will be assessed during this observation period and used as a control group. After the observation period, patients will undergo the AquaPass procedure 2-3 times a week for 4 weeks. Study assessments will be conducted at the beginning of each week during the patient's dialysis session.

Device: The AquaPass System

Interventions

The AquaPass System DEVICE

The system is a non-invasive, renal-independent, single-patient, multiple-use device intended for use at the hospital, outpatient clinic, or home. The system administers warm, dry air around the patient's body to create an environmental condition that activates the eccrine glands to produce sweat, in return it removes fluids from the interstitial compartment, where fluids accumulate in fluid overload.

adult patients undergoing regular hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AquaPass Medical Ltd.: lead

Study Sites (1)

Nazareth Hospital EMMS

Nazareth, Al Wadi Al Jawani 1611, 16100, Israel

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zaher Armaly, MD

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: April 10, 2024
• Study Start: March 29, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 7, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)