NCT04578353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2022

Completed
Last Updated

November 1, 2023

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

September 25, 2020

Last Update Submit

October 31, 2023

Conditions

Chronic Heart Failure

Keywords

CHFEdema

Outcome Measures

Primary Outcomes (3)

  • Safety Events

    Device related SAE

    30 days

  • System Activation

    Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C

    During procedure

  • Treatment Toleration

    Subjects can tolerate at least 2 hours of treatment

    During procedure

Other Outcomes (9)

  • Skin Changes

    Before and and immediately after procedure

  • CBC

    Before and and immediately after procedure

  • NT-proBNP (phase 2 only)

    Before and and immediately after procedure

  • +6 more other outcomes

Study Arms (1)

AquaPass System

EXPERIMENTAL

Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure.

Device: The AquaPass System

Interventions

The AquaPass SystemDEVICE

The AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate.

AquaPass System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1: Healthy subjects:
  • Age ≥ 18
  • Subject has been informed on the nature of the study and has provided informed consent
  • Subject is capable of meeting study requirements
  • Phase 2: CHF Patients:
  • 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

You may not qualify if:

  • Phase 1: Healthy subjects:
  • 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
  • Phase 2: CHF Patients:
  • 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
  • Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
  • Subject has known sensitivity to Neoprene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Related Publications (1)

  • Aronson D, Nitzan Y, Petcherski S, Bravo E, Habib M, Burkhoff D, Abraham WT. Enhancing Sweat Rate Using a Novel Device for the Treatment of Congestion in Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e009787. doi: 10.1161/CIRCHEARTFAILURE.122.009787. Epub 2022 Nov 2.

    PMID: 36321445DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doron Aronson, Professor

    (Director, Inpatient Cardiology Unit (Rambam Health Care Campus)

    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

September 25, 2020

First Posted

October 8, 2020

Study Start

January 28, 2020

Primary Completion

February 12, 2022

Study Completion

June 12, 2022

Last Updated

November 1, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)