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Investigation of Non-CE Marked Intermittent Catheters for Females

NCT04557787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-21

Study results available
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Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.

Conditions

  • Retention, Urinary

Interventions

DEVICE

SpeediCath® Standard female

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard female.

DEVICE

New intermittent Variant 1 catheter for females

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.

DEVICE

New intermittent Variant 2 catheter for females

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Per Bagi, MD · Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Denmark

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 NCT04557787 on ClinicalTrials.gov