One Piece Drainable Pouch in Subjects With an Ileostomy

NCT01939106 | Completed Phase 2

• 1 other identifier: CC-0512-13-A740
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ileostomy

Keywords

Stoma; Ileostomy; pouch; Drainable Pouch for collection of stool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance/Efficacy

  The study will be for 10 days

Study Arms (1)

One Piece Drainable Pouch

OTHER

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

Interventions

One Piece Drainable Pouch DEVICE

Also known as: Enhanced one piece drainable pouch

One Piece Drainable Pouch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Of legal consenting age and able to provide written informed consent
• Is able to read, write, and understand the primary language of the investigative site.
• Have an ileostomy for more than 3 months
• 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)
• Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
• Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
• Be willing to wear a one piece drainable pouch with moldable wafer according to the usual wear pattern of this type of pouch
• Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
• Be willing to remain in residence for 3 days at a central location
• Be willing to meet with the investigator for a total of nine scheduled visits.
• 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
• 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

You may not qualify if:

• Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
• Subjects with stoma duration of less than 3 months
• Subjects who currently use a belt with their usual appliance
• Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
• Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
• Subjects undergoing chemotherapy or radiotherapy

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Independent Nurse Consultant LLC

Tucson, Arizona, 85742, United States

Location

Study Officials

• Ann Popavich-Durnal, RN BSN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: September 11, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

US (1)