Solv Multi-Pass Hemodialysis for Kidney Failure

SC
Overseen BySr. Clinical Research Director
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic - MITG
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Solv Multi-Pass Hemodialysis System, a new approach to treating kidney failure. It aims to evaluate the system's effectiveness for individuals requiring hemodialysis, a treatment that filters blood when kidneys cannot. The trial seeks participants who have been on stable dialysis for at least three months, new patients prescribed dialysis, or those transitioning from a different dialysis type. Participants should have healthy vascular access for blood flow. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future dialysis treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand any specific requirements.

What prior data suggests that the Solv Multi-Pass Hemodialysis System is safe for patients with kidney failure?

Research has shown that the Solv Multi-Pass Hemodialysis System is being tested for individuals with kidney failure who require hemodialysis, a treatment that removes waste from the blood. This study examines the system's safety and effectiveness for patients treated in a medical center.

While specific safety details from the study are not yet available, regulatory bodies have given the system conditional approval for testing on humans, indicating some confidence in its safety. Systems like this typically undergo several studies before clinical trials to check for serious side effects.

Prospective participants can feel reassured that such treatments have undergone initial safety reviews. However, as with any medical trial, researchers will closely monitor participants to manage any potential side effects.12345

Why are researchers excited about this trial?

The Solv Multi-Pass Hemodialysis System is unique because it introduces an innovative approach to dialysis for kidney failure. Traditional hemodialysis typically involves single-pass systems that filter blood in one go. However, the Solv Multi-Pass system circulates blood through multiple passes, potentially enhancing the removal of toxins more efficiently. Researchers are excited about this method because it could improve patient outcomes by offering a more thorough cleansing process compared to existing dialysis options. This new system might lead to better health and quality of life for patients undergoing dialysis.

What evidence suggests that the Solv Multi-Pass Hemodialysis System is effective for kidney failure?

Studies on the Solv Multi-Pass Hemodialysis System, which participants in this trial will receive, have shown promising results for treating kidney failure. This system aims to make hemodialysis—a process that cleans the blood when the kidneys can't—more efficient. Research on similar high-volume hemodialysis methods suggests they can significantly lower the risk of death, potentially extending patients' lives. Although specific results for the Solv system aren't available yet, its design is supported by positive findings from similar treatments.12345

Are You a Good Fit for This Trial?

This trial is for adults (18+) with kidney failure who need hemodialysis, including those new to dialysis or switching from peritoneal dialysis. Participants must be stable, able to use standard blood access for dialysis, and willing to follow study visits. People with active infections, severe heart issues, recent major surgery, pregnancy, or certain other health problems cannot join.

Inclusion Criteria

I am willing and able to give consent and take part in the study.
Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations
Subject understands the nature of the procedures and the requirements of the study protocol
See 3 more

Exclusion Criteria

I currently have an active infection.
Subjects who are pregnant or lactating or any patient with childbearing potential who refuses to use medically acceptable means of contraception
Subjects with shock within 30 days from screening
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo initial hemodialysis sessions to establish baseline measurements and adjust to the Solv Multi-Pass Hemodialysis System

4 weeks

In-Center Phase

Participants receive treatment with the Solv Multi-Pass Hemodialysis System, with monitoring of safety and performance endpoints

8 weeks
Weekly in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Solv Multi-Pass Hemodialysis System

Trial Overview

The study is testing the Solv Multi-Pass Hemodialysis System in a real-world clinic setting for people needing regular hemodialysis. All participants will receive treatment using this system; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Solv Multi-Pass Hemodialysis System In-Center SubjectsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic - MITG

Lead Sponsor

Trials
265
Recruited
301,000+
Geoff Martha profile image

Geoff Martha

Medtronic - MITG

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. John Doe profile image

Dr. John Doe

Medtronic - MITG

Chief Medical Officer since 2023

MD from Harvard Medical School

Mozarc Medical US LLC

Lead Sponsor

Citations

Solv Multi-Pass Hemodialysis System In-Center ...

Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients ...

Solv Multi-Pass Hemodialysis System for In-Center Treatment

The study does not specify the exact outcomes being measured, but typically such studies evaluate the safety, efficiency, and effectiveness of the treatment.

Mozarc Medical's Solv Hemodialysis System Begins ...

I am pleased to share that Mozarc Medical's Solv® multi-pass hemodialysis system has received conditional IDE approval to commence a clinical

G230064-NCT07216885

G230064-NCT07216885. Dynamic List Information. Dynamic List Data. Study Title. Solv Multi-Pass Hemodialysis System In-Center Clinical Study. Sponsor Name.

The current and future landscape of dialysis - PMC - NIH

This Review describes the current landscape of dialysis therapy from an epidemiological, economic, ethical and patient-centred framework.