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Performance of a Single-use Intermittent Micro-hole Zone Catheter

NCT05485922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-03-05

Study results available
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Summary

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.

The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Conditions

Interventions

DEVICE

Investigational device - intermittent catheter with a micro-hole zone

The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

DEVICE

Comparator device -VaPro intermittent catheter

The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Cecilie Rovsing, MD · Sanos

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2022-11-04
Completion
2022-11-04

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT05485922 on ClinicalTrials.gov