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TerminatedNCT01782196U366Updated Jul 3, 2013

A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy

An interventional study of Enhanced one piece drainable pouch with Type A mouldable adhesive and Enhanced one piece drainable pouch with Type B mouldable adhesive in Ileostomy, sponsored by ConvaTec Inc.. Terminated at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-03.

Sponsored by ConvaTec Inc. · Not applicable, Interventional, and Supportive care

Why this study was terminated
Leakage
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.

02

Conditions studied

  • Ileostomy
03

In context

Lead sponsor

ConvaTec Inc. is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who provide written informed consent.
  • Subjects who have an ileostomy and be over 18 years of age.
  • Subjects who are currently using a one piece drainable pouch.
  • Subjects who have unbroken peri-stomal skin (healthy normal skin defined as "normal unbroken skin with certain variations normal for this subject" to L1 on the SACs Instrument Scale).
  • Subjects with a stoma considered 'normal' in appearance in accordance with the stoma, colour, moisture and structure rating scales.
  • Subjects who are willing to attend clinic for a maximum of 5 separate occasions for scheduled visits.
  • Subjects who are 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.
  • Subjects who other than their ileostomy considered to have a healthy/stable health status.
  • Subjects who have good manual dexterity and be able to take care of their stoma independently, or have a consistent care provider.
  • Subjects who are willing and able to complete a diary card for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • 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, rings, seals) to even undulations of the skin.
  • Subjects undergoing chemotherapy or radiotherapy.
  • Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Type A Pouch followed by Type B pouch

    Enhanced one piece drainable pouch with Type A mouldable adhesive for Stage 1 and 2 followed by pouch with Type B mouldable adhesive for Stage 3

    Device: Enhanced one piece drainable pouch with Type A mouldable adhesive · Device: Enhanced one piece drainable pouch with Type B mouldable adhesive

  • Experimental
    Type B Pouch followed by Type A pouch

    Enhanced one piece drainable pouch with Type B mouldable adhesive for Stage 1 and 2 followed by pouch with Type A mouldable adhesive for Stage 3

    Device: Enhanced one piece drainable pouch with Type A mouldable adhesive · Device: Enhanced one piece drainable pouch with Type B mouldable adhesive

Interventions

  • DeviceEnhanced one piece drainable pouch with Type A mouldable adhesive
  • DeviceEnhanced one piece drainable pouch with Type B mouldable adhesive
06

What researchers measure

Primary outcomes

  1. Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions

    The primary objective of this study is to evaluate the safety of the enhanced one piece drainable pouch with a mouldable skin barrier wafer and two alternate adhesives in subjects with an ileostomy.

    Time frame: 59 days

Secondary outcomes

  1. Performance

    Performance will be evaluated by comparing the following categories to the subject's usual pouching system Wear time Adhesion Ease of Use Mouldability Comfort and flexibility Security Skin protection Wafer seal integrity Undermining Filter performance Accessory usage At the end of the study a comparative assessment of the subject's usual pouching system and the study pouch will be made.

    Time frame: 59 days

07

Study locations

5 sites
  • Princess of Wales Hospital
    Bridgend, Mid Glam CF31 1RQ, United Kingdom
  • Wrexham Maelor Hospital
    Wrexham, North Wales LL13 7TD, United Kingdom
  • Musgrove Park Hospital
    Taunton, Somerset TA1 5DA, United Kingdom
  • Manor Hospital
    Walsall, West Midlands WS2 9PS, United Kingdom
  • Homerton University Hospital
    London, E9 6SR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01782196
Lead sponsor
ConvaTec Inc.
Responsible party
Sponsor
First posted
Feb 1, 2013
Start date
Oct 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jul 3, 2013
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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