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Assessment of New Ostomy Devices in Subjects Having an Ileostomy

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ClinicalTrials.gov Identifier: NCT03427203
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

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

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: SenSura Mio Device: Coloplast Ostomy device 1 Device: Coloplast Ostomy device Device: Coloplast Ostomy device 3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : April 6, 2018
Actual Study Completion Date : April 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Experimental: Arm 1

The subjects test the products in the following order

SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3

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

Experimental: Arm 2

The subjects test the products in the following order

SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2

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




Primary Outcome Measures :
  1. Trans epidermal water loss [ Time Frame: 14 days ]
    Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have given written informed consent and in DK: signed a letter of authority
  2. Be at least 18 years of age and have full legal capacity
  3. Have had their ileostomy for at least 3 months
  4. Must be able to use custom cut product
  5. Can use a product with max cut size 45 mm
  6. Self-reported problems with leakage (3 x within 14 days)
  7. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

  1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
  2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
  3. Are pregnant or breastfeeding
  4. Are participating in other interventional clinical investigations or have previously participated in this investigation 4.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol.
  5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
  6. Have known hypersensitivity towards any of the products used in the investigation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427203


Locations
Denmark
Coloplast A/S
Humlebæk, Denmark, 3050
CCBR Vejle
Vejle, Denmark, 7100
Netherlands
QPS Netherlands
Groningen, Netherlands, 9713
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Birte P Jakobsen, MD Medical Director

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT03427203     History of Changes
Other Study ID Numbers: CP264
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No