Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

February 26, 2014 updated by: Coloplast A/S

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Humlebæk, Denmark
        • Coloplast A/S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Be able to handle the bags themselves or with help from caregiver
  • Have an ileostomy with a diameter between 15 and 45 mm
  • Have had their ostomy for at least three months
  • Currently use a 1-piece flat standard care product with open bag
  • Negative result of a pregnancy test for women of childbearing age
  • Custom-cut product user
  • Be suitable for participation in the investigation

Exclusion Criteria:

  • Use irrigation during the study (flush the stoma with water)
  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
  • Are pregnant or breastfeeding
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Max three days wear time
  • Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Treatment 1; First Coloplast Test product 1

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects first testing Coloplast Test product 1 are randomised to secondly test either:

  1. Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
  2. Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
Device: Coloplast Test product 1
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
Device: Coloplast Test product 2
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Standard Care was the subject usual ostomy appliance and had to be one of the following:

  • Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,
  • Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate
  • ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate
EXPERIMENTAL: Treatment 2; First Coloplast Test product 2.

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects first testing Coloplast Test product 2 are randomised to secondly test either:

  1. Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
  2. Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1
Device: Coloplast Test product 1
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
Device: Coloplast Test product 2
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Standard Care was the subject usual ostomy appliance and had to be one of the following:

  • Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,
  • Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate
  • ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate
EXPERIMENTAL: Treatment 3,First Standard care (see below)

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either:

  1. Coloplast Test product 1 and thereafter Coloplast Test product 2
  2. Coloplast Test product 2 and thereafter Coloplast Test product 1
Device: Coloplast Test product 1
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
Device: Coloplast Test product 2
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Standard Care was the subject usual ostomy appliance and had to be one of the following:

  • Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,
  • Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate
  • ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of Leakage
Time Frame: Up to 14 days per test product
The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
Up to 14 days per test product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birte Petersen, Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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