One Piece Drainable Pouch in Subjects With an Ileostomy

Ileostomy Clinical Trial

Official title:

A Single Center Study to Assess the Safety and Performance of a One Piece Drainable Pouch in Subjects With an Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939106
• Other study ID #: CC-0512-13-A740
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2013
• Last updated: September 5, 2013
• Start date: June 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy

Intervention

Device:
• One Piece Drainable Pouch

Locations

Country	Name	City	State
United States	Independent Nurse Consultant LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	To assess the condition of the peristomal skin and stoma and number and frequency of adverse events	Study duration will be 10 days
Secondary	Performance/Efficacy	To assess ease of use including ease of application and removal, comfort and security along with wear time	The study will be for 10 days