Ileostomy - Stoma
Conditions
Brief summary
The aim of the current clinical investigation is to evaluate a new filter
Detailed description
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
Interventions
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age and have full legal capacity. * Have given written informed consent. * Be able to fill in the Case Report Form. * Be ileostomy operated and have had a stoma for at least 6 months. * Experience ballooning at least once per week. * Be able to manage the bags themselves (application, removal). * Be able to use a flat base plate. * Have a stoma with a diameter less than 60 mm
Exclusion criteria
* Persons who irrigate * Currently suffer from peristomal skin problems (i.e. bleeding or broken skin). * Currently receiving or have within the past 2 months received radio- and/or chemotherapy. * Pregnant or breastfeeding. * Participate in other test at the same time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | Daily or at every change of bag in a period of a maximum of 28 days | Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period. |
Countries
Denmark
Participant flow
Recruitment details
The subjects were recruited from a user data base in Denmark.
Pre-assignment details
20 subjects were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Sensura The reference product is the SenSura product which is already commercially available | 10 |
| Morfeus The test product is the product with the proposed new filter (Morfeus) | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (14 Days) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Sensura | Morfeus | Total |
|---|---|---|---|
| Age Continuous | 59 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
Primary
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.
Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
Time frame: Daily or at every change of bag in a period of a maximum of 28 days
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensura | Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | 55 percentage bags with ballooning |
| Morfeus | Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | 26 percentage bags with ballooning |