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Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure

NCT06689553 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-05-15

No results posted yet for this study

Summary

The study aims to assess the feasibility, safety, tolerability and functionality of a percutaneously delivered automated continual fluid removal System in up to 8 patients with Heart Failure (HF) and diuretic resistance.

Intervention: Implanted absorption chamber, connected to an external pump. Follow up: 6 months post activation.

Conditions

Interventions

DEVICE

Automated Continual Fluid Removal System

The intraperitoneal device is percutaneously implanted via mini laparotomy, under local anaesthesia and sedation, and connected to the wearable rechargeable pump through extracorporeal tubing. The device aims to remove excess fluids in heart failure patients with diuretic resistance

Sponsors & Collaborators

  • Paragate Medical LTD

    lead INDUSTRY

Principal Investigators

  • Marko Banović, MD · University Clinical Centre of Serbia

  • Marija Zdravkovic, MD · University Clinical Hospital Medical Center "Bezanijska kosa"

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-28
Primary Completion
2026-05-05
Completion
2026-05-05

Countries

  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT06689553 on ClinicalTrials.gov