Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

NCT02887144 | Completed

• 1 other identifier: Coloplast - CP257
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Degree of leakage

  Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.

  patients will test the products for 4 weeks

Study Arms (2)

SenSura test product 1pc

EXPERIMENTAL

Subjects randomized to treatment sequence 1test: 1. SenSura test product 2. SenSura

Device: SenSura; Device: SenSura test product

SenSura 1pc

EXPERIMENTAL

Subjects randomized to treatment sequence 2 test: 1. SenSura 2. SunSura test product

Device: SenSura; Device: SenSura test product

Interventions

SenSura DEVICE

SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S

SenSura 1pc; SenSura test product 1pc

SenSura test product DEVICE

SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S

SenSura 1pc; SenSura test product 1pc

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
• Be at least 18 years of age and have full legal capacity
• Be able to handle the products themselves
• Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
• Have had their ileostomy for at least 3 months
• Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
• Currently using midi or maxi bags
• Willing to use minimum 1 product every second day (max. 2 days wear time)
• Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
• Must be able to cut products themselves

You may not qualify if:

• Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
• Currently receiving or have received within the past month 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
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity of the product components and/or ingredients

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: September 2, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)