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Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01272869
First received: December 14, 2010
Last updated: November 29, 2012
Last verified: November 2012

December 14, 2010
November 29, 2012
January 2011
March 2011   (final data collection date for primary outcome measure)
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
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.
Difference in ballooning frequency between test filter and reference filter [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01272869 on ClinicalTrials.gov Archive Site
Not Provided
  • Time to ballooning [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
    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 time the product was attached and removed.Subjects will change bag according to their normal routine or when deemed appropriate. Furthermore the following secondary endpoints will be measured:pancaking, odor, discretion using the bag, preference, demographics and baseline data and safety.These data will be recorded during the study.
  • Frequency of pancaking (the bag was sucked together and completely emptied of air) [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
    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 if they experienced pancaking of the bag. Subjects will change bag according to their normal routine or when deemed appropriate.
  • Frequency of odor (registered by the subjects if they experience odor problems) [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
    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 if they experienced odor from the bag. Subjects will change bag according to their normal routine or when deemed appropriate.
  • Discretion using the bag [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
    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 how bothered they were using the bag (visually).
  • Distribution of preference (preference of reference product versus test product) [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
    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 whether they prefer the test or the reference product.
  • Registration of adverse events and serious adverse events as a measure of safety [ Time Frame: During the investigation ~ 28 days per subject ] [ Designated as safety issue: Yes ]
    Safety is continuously evaluated while the subjects are testing the devices. Subjects are furthermore instructed to record adverse events after each test period and advised to contact the Principal Investigator immediately if they experience adverse events during the investigation.
Not Provided
Not Provided
 
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

The aim of the current clinical investigation is to evaluate a new filter

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Ileostomy - Stoma
  • Device: SenSura
    The ostomy bag filter will be tested for a period of 14 days
    Other Name: SenSura
  • Device: Morfeus
    The new ostomy bag filter will be tested for a period of 14 days
    Other Name: Morfeus
  • Active Comparator: Sensura
    SenSura is the reference product and the product is already commercially available
    Intervention: Device: SenSura
  • Experimental: Morfeus
    The test product is the product with the proposed new filter (Morfeus)
    Intervention: Device: Morfeus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01272869
CP211OC
No
Coloplast A/S
Coloplast A/S
Not Provided
Study Chair: Daniel Carter, MSc Coloplast A/S
Coloplast A/S
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP