Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy

NCT03439241 | Completed

• 1 other identifier: CP278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose was to investigate the performance of a new ostomy device measured with a measuring device.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• wear time (hours)

  Wear time is recorded at each baseplate change

  14 days

Study Arms (2)

Silent arm

EXPERIMENTAL

The participants test the new Coloplast ostomy device use the product as they usually would.

Device: Coloplast ostomy device

Active arm

EXPERIMENTAL

The participants test the tnew Coloplast ostomy device and are guided by the measuring device

Device: Coloplast ostomy device

Interventions

Coloplast ostomy device DEVICE

the test product is a newly developed Coloplast ostomy device

Active arm; Silent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent and in DK: signed a letter of authority
• Be at least 18 years of age and have full legal capacity
• Have had their ileostomy for at least 3 months
• Can use a product with max cut size 45 mm
• Self-reported problems with leakage (3 x within 14 days)
• Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period
• Must be able to use custom cut product
• Minimum change of product every third day
• Get a negative result of a pregnancy test for women of childbearing age (only DK)

You may not qualify if:

• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is 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. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
• Are pregnant or breastfeeding
• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Officials

• Birte P Jakobsen, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 20, 2018
• Study Start: February 5, 2018
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

DK (1)