MedTrace Logo

A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

NCT03154944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-28

Study results available
· View outcomes & findings →

Summary

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Ostomy device 1

This device consists of a known adhesive and a new top film

DEVICE

Ostomy device 2

This device consists of a new adhesive and a known top film

DEVICE

Ostomy device 3

This device consists of a known adhesive and a new top film

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte P Jakosen, MD · Medial director

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2018-02-02
Completion
2018-02-02

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 NCT03154944 on ClinicalTrials.gov