CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
SpeediCath® Standard male or female +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04445051
NCT04445051N/ACompleted
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Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Coloplast A/S·interventional·Posted Jun 24, 2020·Updated Jul 3, 2023

In Brief

A clinical study evaluating SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, and 1 other intervention for Retention, Urinary. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetention, Urinary
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 24, 2020
Enrollment StartMar 1, 2020
Primary CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.0 years ago

Interventions

SpeediCath® Standard male or femaledevice

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

New intermittent Variant 1 catheter for male or femaledevice

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

New intermittent Variant 2 catheter for male or femaledevice

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