A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA

NCT05342935 | Unknown

• 1 other identifier: liberDi
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, open label, cross-over clinical study. A total of 15 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home. The study includes three periods: First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time. Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule. Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.

Conditions

Chronic Kidney Disease Stage V

Outcome Measures

Primary Outcomes (1)

• Safety Endpoint - Serious Adverse Events Rate

  The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period

  42 days

Secondary Outcomes (3)

• IDA Usability by Investigator

  14 days

• IDA Usability by Subject

  14 days

• IDA Feasibility

  14 days

Study Arms (1)

IDA treatment

EXPERIMENTAL

Each subject will be treated with his prescribed manual PD for 14 days, followed by a treatment period of 14 days with the investigational IDA system, and concluding with additional 14 days of treatment with the manual PD.

Device: Inteligent Dialysis Assistant (IDA)

Interventions

Inteligent Dialysis Assistant (IDA) DEVICE

The IDA is a small dialysis system that allows a higher level of freedom to the patients, permitting them to perform the PD exchange while continuing to do their everyday activities

IDA treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects with CKD stage 5 under peritoneal dialysis
• Age ≥18 years
• Mental ability to understand the study procedures and provide informed consent
• At least 3 months on peritoneal dialysis prior to enrollment
• At least 3 daily exchanges
• Stable PD prescription for the last 2 months
• Subject who is self-treated

You may not qualify if:

• Need of cycler (APD)
• Known Mechanical problem during the last month (i.e. drainage or fill problems)
• Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
• Subjects who are unwilling or unable to comply with study procedures
• Known Peritonitis or other catheter related infection during the last 3 months prior to enrollment
• Known Congestive Heart Failure stage III-IV
• Any history of kidney malignancy
• Any planned hospitalization for elective Procedure(s)throughout the duration of participation in the study
• Non-elective hospitalization in the last 3 months prior to enrollment
• Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
• Participation in any other clinical study within 4 weeks prior to enrollment

Sponsors & Collaborators

• liberDi Ltd.: lead

Study Officials

• Richard Corbett, MD

  Imperial College Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Shick

CONTACT

97248228090; maya@liberdi.com

Study Design

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

Model Details: Subjects will pursue their usual manual PD exchanges, followed by the treatment with the investigational device and then back to their manual PD.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04