Clinical Investigation Exploring Two Ostomy Product Prototypes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2024-02-02

Brief Summary

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Two ostomy product prototypes (Test product A and B) will be tested in this investigation.

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.

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Detailed Description

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Conditions

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Stoma Ileostomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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one-armed study

Group Type EXPERIMENTAL

CP363

Intervention Type DEVICE

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.

Interventions

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CP363

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Has given written informed consent
2. Is at least 18 years of age and has full legal capacity
3. Has had an ileostomy for more than 3 months
4. Has suitable peristomal skin area (assessed by investigator)
5. Is currently using flat SenSura Mio 1-piece or 2-piece
6. Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days
7. Has a stoma size less than 45mm in diameter

Exclusion Criteria

1. Is currently receiving or have within the past 60 days received radio- and/or chemotherapy (Low doses radio- and/or chemotherapy (Assessed by Principal Investigator) is allowed. for indications other than cancer)
2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g. lotion or spray or systemic steroid (tablet/injection) treatment
3. Is pregnant or breastfeeding
4. Has dermatological problems in the peristomal area (assessed by investigator)
6. Has any known allergies towards ingredients in the investigational device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No