Renal Assist Device (RAD) for Patients With Renal Insuffi... | NCT05990660

Studies
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

NCT05990660

Sponsor

3ive Labs

Status

Completed

Last Update Posted

Jan 23, 2024Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Renal Insufficiency
Acute Kidney Injury

Interventions

JuxtaFlow System

Countries

Poland
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2023Actual

Primary Completion Date

Dec 28, 2023Actual

Completion Date

Jan 18, 2024Actual

First Submitted Date

Aug 7, 2023

First Submission Date that Met QC Criteria

Aug 7, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2024

Last Update Posted Date

Jan 23, 2024Actual

Name	Class
SCIRENT	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

Detailed Description

The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: JuxtaFlow System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JuxtaFlow System	Device	Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
[Safety] Adverse Events Characterization	The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.	30 days
[Efficacy] Creatinine Clearance	The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.	24 hours
[Efficacy] Urine Sodium Excretion	The change in urine sodium excretion occurring over the treatment period of 24 hours or less.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidate cardiac surgical patients
Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
Age 22 to 85 years
eGFR < 60 mL/min/1.73m2
Signed informed consent

Exclusion Criteria:

End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
Planned off-pump surgery
Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL)
Pregnancy
Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Slobodan Micovic, MD	Institute for Cardiovascular Diseases Dedinje	Principal Investigator
Milovan Petrovic, MD	Institute of Cardiovascular Diseases of Vojvodina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii		Krakow	Bielsko-Biata	43-316	Poland
Institute for Cardiovascular Diseases "Dedinje"

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D058186	Acute Kidney Injury
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided