MedTrace Logo

Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

NCT04633291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-07-17

Study results available
· View outcomes & findings →

Summary

Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.

Conditions

  • Catheter Site Pain
  • Catheter Site Discomfort

Interventions

DEVICE

Novel swelling media

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

DEVICE

Comparator swelling media

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2019-11-28
Completion
2019-11-28

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT04633291 on ClinicalTrials.gov