Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-07-29

Brief Summary

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The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are:

* the success of AWAK PD therapies when used in a home-setting
* the safety and effectiveness of the AWAK PD system

Participants will:

* be titrated to find a suitable AWAK PD prescription
* be trained on how to use the AWAK PD system independently
* use the AWAK PD system at home for at least 7 days

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Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AWAK PD

Wearable/Ultra-portable peritoneal dialysis device for home-use

Group Type EXPERIMENTAL

AWAK PD

Intervention Type DEVICE

Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy

Interventions

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AWAK PD

Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent to participate in the study.
2. Male or female ≥22 years of age.
3. Treated with PD for at least 3 months before Screening.
4. Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
5. No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.

Exclusion Criteria

1. Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good investigation candidate
2. Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
3. Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
4. Poorly controlled diabetes mellitus as defined by hemoglobin A1c \>9.0% during Screening
5. Subject has a current abdominal hernia.
6. Subject has an active infection requiring systemic antibiotics or antifungal therapy.
7. Active infection of hepatitis B and C, or HIV infection at any time.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No