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Evaluation of a New Female Urinary Intermittent Catheter

NCT04304599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-28

No results posted yet for this study

Summary

A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.

Conditions

  • Female Intermittent Urethral Catheterization

Interventions

DEVICE

LoFric Elle

The study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Pernilla Sundqvist, MD, PhD · Örebro University Hospital, Sweden

  • Kaj Stenlöf, Dr. · Carlanderska Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2023-01-03
Completion
2023-02-27

Countries

  • Spain
  • Sweden

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 NCT04304599 on ClinicalTrials.gov