Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

December 8, 2015 updated by: Coloplast A/S

Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

The aim of the investigation was to investigate the performance and safety of a new ostomy product.

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.
129

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
      • Søborg, Denmark
        • TFS
  • France
      • Dijon cedex, France, 21079
        • Hôpital du Bocage
      • Libourne cedex, France, 33505
        • Hôpital Robert Boulin
      • Lille cedex, France, 59037
        • Hopital Claude Huriez
      • Marseille, France, 13015
        • Hopital Nord
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75014
        • Hôpital Cochin
      • Pessac cedex, France, 33604
        • Hopital De Haut Leveque
      • Poitiers Cedex, France, 86021
        • CHRU La Milétrie
  • Germany
      • Aachen, Germany
        • BB medica medizinisches
      • Augsburg, Germany
        • Sanitätshause reinhold hilscher e.K.
      • Bad Staffelstein, Germany
        • Patientenberatung Strack e.K.
      • Berlin, Germany
        • Pro-samed Santitätshaus
      • Burgdorf, Germany
        • SIEWA Coloplast Homecare
      • Freising, Germany
        • SIEWA Coloplast Homecare
      • Leinfelden-echterdingen, Germany
        • SIEWA Coloplast Homecare
      • Leipzig, Germany
        • Schürmaier GmbH &Co
      • Passau, Germany
        • Sanitätshaus Fürst GmbH
      • Saulgrub, Germany
        • SIEWA Coloplast Homecare
      • Töppeln, Germany
        • Sanitäts- und gesundheitshaus Carqueville GmbH
      • Zwickau, Germany
        • Alippi GmbH
  • Norway
      • Larvik, Norway
        • Sykpleierklinikken
  • United Kingdom
      • Boston, United Kingdom
        • Pilgrim Hospital
      • Cambridge, United Kingdom, CB20QQ
        • Addenbrookes
      • Gloucestershire, United Kingdom, GL53/AI
        • Cheltenham General Hospital
      • Lincoln, United Kingdom, LN25QY
        • Lincon Country hospital
      • London, United Kingdom, W68RF
        • Charing Cross Hospital
      • Northamptonshire, United Kingdom, NN168UZ
        • Kettering General Hospital
      • Suffolk, United Kingdom, IP332QZ
        • West Suffolk Hospital

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:

  1. Are at least 18 years of age and have full legal capacity.
  2. Has had an ileostomy for at least 3 months.
  3. Has used a convex ostomy product for the last month.
  4. Has given signed informed consent.
  5. Has experienced seeping under the baseplate at least three times during the last two weeks.
  6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
  7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
  8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria:

  1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
  2. Are pregnant or breastfeeding.
  3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
  4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
  5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
  6. Are currently participating in another clinical intervention study or have previously participated in this one.
  7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
  8. Has known hypersensitivity toward the test product.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: First Coloplast test product

The subjects test:

test period 1: Coloplast test product test period 2: SenSura Convex Light
Device: Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
Device: SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Other Names:
  • SenSura
Experimental: First SenSura Convex Light

The subjects test:

test period 1: SenSura Convex Light test period 2: Coloplast test product
Device: Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
Device: SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Other Names:
  • SenSura

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: 28 +/- 3 days
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
28 +/- 3 days

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.
  • Study Director: Daniel Carter, 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.
November 1, 2013

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.
June 1, 2014

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.
June 1, 2014

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).
October 18, 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.
November 21, 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.
November 26, 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.
January 12, 2016

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.
December 8, 2015

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.
December 1, 2015

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.
  • CP232

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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