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PMCF Study of the CE-marked Drainova® ArgentiC Catheter

NCT06436807 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 169

Last updated 2026-03-12

No results posted yet for this study

Summary

The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.

The main questions of this study are:

* Does the device function as intended?
* Are there any other safety risks that have not been identified?
* Does it lower the symptoms of the patients as intended?

Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.

Conditions

  • Pleural Effusion
  • Pleural Effusion, Malignant
  • Ascites
  • Ascites, Malignant

Interventions

DEVICE

Indwelling catheter

The tunneled catheter is an implant product that enables the drainage of effusion accumulations from serous body cavities so that the symptoms caused by an effusion are relieved by draining off the accumulated fluids.

Sponsors & Collaborators

  • LS medcap GmbH

    collaborator OTHER

  • ewimed GmbH

    lead INDUSTRY

Principal Investigators

  • Heidrun Steinle, Dr · LS medcap GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2025-10-14
Completion
2026-01-09

Countries

  • Germany

Study Locations

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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 NCT06436807 on ClinicalTrials.gov