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Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal Dialysis

NCT05521425 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-09-01

No results posted yet for this study

Summary

Touch contamination during bag exchange in Continuous Ambulatory Peritoneal Dialysis (CAPD) is a common cause of CAPD-related peritonitis. An innovative 3D-printed assistive device "Helping Hands" was designed to minimize direct touch of tubing during CAPD bag exchange to allow a safer connection process for patients with Chronic Kidney Disease (CKD) to reduce the risk of CAPD-related peritonitis. Through this randomized control, the investigators aimed to evaluate the safety and efficacy of "Helping Hands" in CAPD bag exchange procedure for patients on CAPD therapy.

Conditions

  • Renal Failure Chronic

Interventions

DEVICE

"Helping Hands" for CAPD bag exchange procedures

Training served as "Treatment As Usual" (TAU) for all participants; The difference between two groups was whether "Helping hands" were provided to participants for CAPD bag exchange procedures at home.

Sponsors & Collaborators

  • Queen Elizabeth Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Carina HO, APN(Renal) · Renal Unit, Queen Elizabeth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521425 on ClinicalTrials.gov