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User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

NCT04703413 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-28

No results posted yet for this study

Summary

An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.

Conditions

  • Bladder Voiding Dysfunction

Interventions

DEVICE

LoFric® OrigoTM and LoFric® SenseTM

The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Markus Wittebo, M.Sc. Pharm. · Wellspect HealthCare

  • Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med. · Universitätsklinikum Bonn, Germany

  • Antje Foresti, Dr. med. · Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach

  • Alexander Höinghaus, Dr. med. · Gemeinschaftspraxis für Urologie, Dierdorf

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-04-15
Completion
2023-04-15

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 NCT04703413 on ClinicalTrials.gov