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Assessment of New Ostomy Devices in Subjects Having an Ileostomy

NCT03427203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-06-06

No results posted yet for this study

Summary

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

SenSura Mio

SenSura Mio is a marked ostomy device which is used as the comparator in this study

DEVICE

Coloplast Ostomy device 1

Coloplast Ostomy device 1 a newly developed ostomy device

DEVICE

Coloplast Ostomy device

Coloplast Ostomy device 2 a newly developed ostomy device

DEVICE

Coloplast Ostomy device 3

Coloplast Ostomy device 3 a newly developed ostomy device

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte P Jakobsen, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-04-06
Completion
2018-04-06

Countries

  • Denmark
  • Netherlands

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 NCT03427203 on ClinicalTrials.gov