A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)

NCT04808011 | Unknown

• 1 other identifier: CSP-028-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-center, open label, cross-over clinical study. A total of 18 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:

1. 1.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.
2. 2.Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
3. 3.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 5

Outcome Measures

Primary Outcomes (2)

• Device-Related Serious Adverse Event Incidence

  Incidence of device-related SAEs throughout the active investigational phase (14 days).

  14 days

• AE during on site exchange

  Incidence of device-related adverse events during the on-site exchange - phase I of the study.

  1 day

Secondary Outcomes (4)

• Procedure Time Length

  14 days

• Usability Questionnaire

  14 days

• Device-Related Serious Adverse Events Incidence During Follow Up Period

  14 days

• Renal Treatment Internal Questionnaire

  42 days

Study Arms (1)

Treatment

EXPERIMENTAL

Each subjects will be treated with his prescribed dialysis device for 14 days, followed by a treatment period of 30 days with the investigational IDA system, and concluding with additional 14 days of treatment with the prescribed dialysis device.

Device: Intelligent Dialysis Assistant (IDA)

Interventions

Intelligent Dialysis Assistant (IDA) DEVICE

The IDA is intended for home dialysis for subjects who are stage 5 kidney diease patients and who perform Peritoneal Dialysis. The system is used deveral times a day for approximately 20 minutes for each cycle. During the interventional period, subjects will use only the investigational IDA system for their in/out exchanges.

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
• Male or female, Age \>18 years
• Mental ability to understand study procedures and provide an informed consent
• More than 3 months on PD (Peritoneal Dialysis)
• At least 3 daily exchanges
• Self-treated subject
• Stable PD prescription for the last month

You may not qualify if:

• Need of cycler (APD, Automated Peritoneal Dialysis)
• Known mechanical problem (drainage, fill) during the last month prior to enrollment
• Pregnant or breastfeeding women
• subject who is unwilling or unable to comply with study procedures
• Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
• Known Congestive heart failure stage III- IV
• Non-elective hospitalization during 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 Sites (3)

Soroka Medical Center

Beersheba, Israel

RECRUITING

Carmel MC

Haifa, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

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

• Tatiana Tansyochuk, MD

  Carmel MC, Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Shick, b.sc

CONTACT

972523313350; Hila@liberdi.com

Study Design

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

Model Details: The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under the supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home. The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). Subjects will be treated with their routine dialysis device for 14 days, followed by a treatment with the IDA for a period of 30 days, and then an additional period of 14 days of treatment with their routine dialysis device.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 19, 2021
• Study Start: December 22, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 30, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)