Trial Outcomes & Findings for Clinical Investigation for New Filter to Ostomy Bags (NCT NCT01273038)

Results Overview

Data will not be recorded at specific time points due to individual changing patterns (1-3 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Daily or at every change of bag in a period of a maximum of 28 days

Results posted on

2013-04-01

Participant Flow

Subjects were recruited from a user database in Denmark

20 subjects were enrolled and randomized in the study

Participant milestones

Participant milestones
Measure	Morfeus First (Test Filter), Then SenSura (Reference Filter) First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)	SenSura First (Reference Filter), Then Morfeus (Test Filter) First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
First Intervention (14 Days) STARTED	10	10
First Intervention (14 Days) COMPLETED	10	10
First Intervention (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	10	10
Second Intervention (14 Days) COMPLETED	10	8
Second Intervention (14 Days) NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Morfeus First (Test Filter), Then SenSura (Reference Filter) First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)	SenSura First (Reference Filter), Then Morfeus (Test Filter) First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
Second Intervention (14 Days) Adverse Event	0	1
Second Intervention (14 Days) Withdrawal by Subject	0	1

Baseline Characteristics

Clinical Investigation for New Filter to Ostomy Bags

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morfeus (Test Filter) n=10 Participants The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.	SenSura (Reference Filter) n=10 Participants The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.	Total n=20 Participants Total of all reporting groups
Age Continuous	65 years STANDARD_DEVIATION 7 • n=5 Participants	66 years STANDARD_DEVIATION 7 • n=7 Participants	66 years STANDARD_DEVIATION 6 • n=5 Participants
Sex/Gender, Customized Female	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Sex/Gender, Customized Male	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Sex/Gender, Customized Gender information not available	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily or at every change of bag in a period of a maximum of 28 days

Population: ITT

Data will not be recorded at specific time points due to individual changing patterns (1-3 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.

Outcome measures

Outcome measures
Measure	Morfeus (Test Filter) n=526 bags The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.	SenSura (Reference Filter) n=567 bags The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
Frequency of Ballooning in the Morfeus and SenSura Test Period.	23 percentage of bags	11 percentage of bags

Adverse Events

Morfeus (Test Filter)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SenSura (Reference Filter)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Morfeus (Test Filter) n=20 participants at risk The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.	SenSura (Reference Filter) n=20 participants at risk The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
Skin and subcutaneous tissue disorders Skin redness and puritus	5.0% 1/20 • Number of events 1	0.00% 0/20
Gastrointestinal disorders Diarrhoea	0.00% 0/20	5.0% 1/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cold	0.00% 0/20	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Constipation	0.00% 0/20	5.0% 1/20 • Number of events 1
Infections and infestations Influenza	5.0% 1/20 • Number of events 1	5.0% 1/20 • Number of events 1

Additional Information

Director of Medical Affairs

Coloplast A/S

Phone: 4549111111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place