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Investigation of New Intermittent Catheters in Healthy Volunteers

NCT04445051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-03

Study results available
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Summary

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Conditions

  • Retention, Urinary

Interventions

DEVICE

SpeediCath® Standard male or female

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

DEVICE

New intermittent Variant 1 catheter for male or female

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.

DEVICE

New intermittent Variant 2 catheter for male or female

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-09-01
Completion
2020-09-01

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 NCT04445051 on ClinicalTrials.gov