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One Piece Drainable Pouch in Subjects With an Ileostomy

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ClinicalTrials.gov Identifier: NCT01939106
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

Brief Summary:
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.

Condition or disease Intervention/treatment Phase
Ileostomy Device: One Piece Drainable Pouch Phase 2

Detailed Description:
This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Single Center Study to Assess the Safety and Performance of a One Piece Drainable Pouch in Subjects With an Ileostomy
Study Start Date : June 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
One Piece Drainable Pouch
This is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma
Device: One Piece Drainable Pouch
Other Name: Enhanced one piece drainable pouch




Primary Outcome Measures :
  1. Safety [ Time Frame: Study duration will be 10 days ]
    To assess the condition of the peristomal skin and stoma and number and frequency of adverse events


Secondary Outcome Measures :
  1. Performance/Efficacy [ Time Frame: The study will be for 10 days ]
    To assess ease of use including ease of application and removal, comfort and security along with wear time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Of legal consenting age and able to provide written informed consent
  2. Is able to read, write, and understand the primary language of the investigative site.
  3. Have an ileostomy for more than 3 months
  4. Currently a one or two piece drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
  5. Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
  6. Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
  7. Be willing to wear a one piece drainable pouch with moldable wafer according to the usual wear pattern of this type of pouch
  8. Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
  9. Be willing to remain in residence for 3 days at a central location
  10. Be willing to meet with the investigator for a total of nine scheduled visits.
  11. Be willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device
  12. Other than their ileostomy considered to have a healthy/stable health status Have good manual dexterity and be able to take care of their stoma independently Be willing and able to complete a diary card for the duration of the study. Be willing to take photographs of the stoma and pouch on pouch removal

Exclusion Criteria - The following subjects must not be included into the study:

  1. Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
  2. Subjects with stoma duration of less than 3 months
  3. Subjects who currently use a belt with their usual appliance
  4. Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
  5. Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
  6. Subjects undergoing chemotherapy or radiotherapy
  7. Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939106


Locations
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United States, Arizona
Independent Nurse Consultant LLC
Tucson, Arizona, United States, 85742
Sponsors and Collaborators
ConvaTec Inc.
Investigators
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Principal Investigator: Ann Popavich-Durnal, RN BSN

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Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01939106     History of Changes
Other Study ID Numbers: CC-0512-13-A740
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by ConvaTec Inc.:
Stoma
Ileostomy
pouch
Drainable Pouch for collection of stool