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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02887144

Acronym

CP257

Enrollment

Registered

2016-09-02

Start date

2016-01-31

Completion date

2016-08-31

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Ileostomy

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.

Detailed description

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Interventions

DEVICESenSura

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

DEVICESenSura test product

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Be able to handle the products themselves 4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm 5. Have had their ileostomy for at least 3 months 6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month 7. Currently using midi or maxi bags 8. Willing to use minimum 1 product every second day (max. 2 days wear time) 9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form 10. Must be able to cut products themselves

Exclusion criteria

1. Currently receiving or have received within the past 2 months chemo- or/and radiation therapy 2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area 3. Are pregnant or breastfeeding 4. Participating in other interventional clinical investigations or have previously participated in this investigation 5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). 6. Known hypersensitivity of the product components and/or ingredients

Design outcomes

Primary

Measure	Time frame	Description
Degree of leakage	patients will test the products for 4 weeks	Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026