Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Coloplast A/S20 enrolled

Overview

The aim of the current clinical investigation is to evaluate a new filter

The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

SenSuraDEVICE

The ostomy bag filter will be tested for a period of 14 days

MorfeusDEVICE

The new ostomy bag filter will be tested for a period of 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be at least 18 years of age and have full legal capacity. * Have given written informed consent. * Be able to fill in the Case Report Form. * Be ileostomy operated and have had a stoma for at least 6 months. * Experience ballooning at least once per week. * Be able to manage the bags themselves (application, removal). * Be able to use a flat base plate. * Have a stoma with a diameter less than 60 mm Exclusion Criteria: * Persons who irrigate * Currently suffer from peristomal skin problems (i.e. bleeding or broken skin). * Currently receiving or have within the past 2 months received radio- and/or chemotherapy. * Pregnant or breastfeeding. * Participate in other test at the same time.

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.

Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.

Time frame: Daily or at every change of bag in a period of a maximum of 28 days

Data from ClinicalTrials.gov

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