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Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Sponsor
Coloplast A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03770078
Collaborator
(none)
23
Enrollment
4
Locations
1
Arm
3.7
Actual Duration (Months)
5.8
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study investigates the performance of a new adhesive with regard to the skin condition

Condition or Disease Intervention/Treatment Phase
  • Device: Test Product A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Actual Study Start Date :
Nov 12, 2018
Actual Primary Completion Date :
Mar 6, 2019
Actual Study Completion Date :
Mar 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study period

First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)

Device: Test Product A
The test product is a newly developed ostomy product

Outcome Measures

Primary Outcome Measures

  1. Trans Epidermal Water Loss [Four weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Have given written informed consent

  • Have an ileostomy or a colostomy with liquid* output (as their usual output)

  • Be at least 18 years of age and have full legal capacity

  • Have had their stoma for at least three months

  • Be able to use products with max cut size 45 mm

  • Have self-reported problems with leakage** (three times within 14 days)

  • Handle the Clinical App, test product and comparator product themselves

  • Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product

  • Minimum change of baseplate at least once every 3rd day

  • Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation

  • Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion Criteria:

  • Are currently receiving or have within the past two 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)

  • Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).

  • Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)

  • Are breast feeding

  • Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

Participation in other Coloplast in-house clinical investigations is 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 (CP300) protocol.

  • Have known hypersensitivity towards any of the products used in the investigation

Contacts and Locations

Locations

Site City State Country Postal Code
1 CCBR Aalborg Aalborg Denmark 9000
2 Coloplast Humlebæk Denmark 3050
3 CCBR Vejle Vejle Denmark 7100
4 KTA Prim Stockholm Stockholm Sweden 11361

Sponsors and Collaborators

  • Coloplast A/S

Investigators

  • Principal Investigator: Birte P Jakobsen, MD, Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT03770078
Other Study ID Numbers:
  • CP300
First Posted:
Dec 10, 2018
Last Update Posted:
Sep 3, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 3, 2020