Clinical Evaluation of the PowerGlide™ Pro Midline Catheter (Midline)

November 16, 2023 updated by: University Hospital Augsburg
Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases. The selected patients are in need of a long-term i.v. therapy for reasons as antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86165
        • University Hospital Augsburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients in the vascular surgery department with above mentioned inclusion criteria

Description

Inclusion Criteria:

  • need for i.v. therapy longer than 7 days
  • poor peripheral vein status
  • Administration of alprostadil

Exclusion Criteria:

  • pending dialysis
  • allergy to catheter material
  • minor age
  • life threatening conditions
  • requirement for central venous catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dwelling Time
Time Frame: 0-29 days
Length of catheter in situ time
0-29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter Complications
Time Frame: 0-29 days
Site complications as thrombophlebitis and occlusion
0-29 days
Administration of Alprostadil
Time Frame: 0-29 days
Feasibility for the usage of Alprostadil measured by patients with development of thrombophlebitis or occlusion
0-29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Augsburg

Investigators

  • Study Director: Alexander Hyhlik-Duerr, PhD, University Hospital Augsburg Vascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 13, 2020

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MIDLINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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