Clinical Evaluation of the PowerGlide™ Pro Midline Catheter | NCT06037525

Studies
Clinical Evaluation of the PowerGlide™ Pro Midline Catheter

NCT06037525

Sponsor

University Hospital Augsburg

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Pain
Catheter Infection

Interventions

PowerGlide™ Pro Midline Catheter

Countries

Germany

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

Nov 2023

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

Jan 1, 2018Actual

Primary Completion Date

Nov 13, 2020Actual

Completion Date

May 1, 2023Actual

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 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

Nov 16, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PowerGlide™ Pro Midline Catheter	Device	Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular disease

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients in the vascular surgery department with above mentioned inclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Hyhlik-Duerr, PhD	University Hospital Augsburg Vascular Surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Augsburg		Augsburg		86165	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided