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Completed

NCT Number: NCT06547905

Evaluation of an Ostomy Leakage Detection System

This study will evaluate the safety and efficacy of an ostomy leakage detection system.

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Key information

Conditions

Ostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park

Cambridge, Cambridgeshire, CB21 6GQ, United Kingdom

About this study

Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or Older
  • Currently resides in the United Kingdom
  • Has an ileostomy, colostomy, or urostomy
  • Has a stoma diameter within the following range: 15 mm - 70 mm
  • Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).
  • Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days
  • Willing to use their typical ostomy pouching system together with the study product for duration of study
  • Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS):
  • a. Android Devices:
  • i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel
  • ii. Operating System: Android OS 9.0 (Pie) and later
  • b. Apple iPhones:
  • i. Compatible Models: iPhone X and later
  • ii. Operating System: iPhone Operating System (iOS) 15 and newer
  • Is willing to download the phone application for use during the study
  • Is willing to follow protocol procedures, as indicated by signing the informed consent
  • Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)

Exclusion criteria

  • Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
  • Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
  • Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
  • Reports as legally blind and/or deaf
  • Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
  • Subject reports currently having an abdominal fistula or abdominal wound
  • Subject has more than one stoma
  • Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
  • Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility.
  • Is currently involved in another research study involving use of ostomy study products or accessories
  • Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories

Treatment and study plan

Ostomy Leakage Detection System

Device

A system that is used to detect ostomy leaks

Primary outcomes

  1. The Accuracy of the Leakage Detection System (LDS)

    Time frame: through study completion, approximately 1 month

    The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.

Secondary outcomes

  1. How adherent subjects are to leakage notifications (ratio)

    Time frame: through study completion, approximately 1 month

    The proportion of barriers that are changed due to accurate leakage notifications will yield insights into how adherent subjects are to leakage notifications.

  2. How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)

    Time frame: through study completion, approximately 1 month

    The ratio of the number of times subjects were alerted to leakage prior to a CL occurring to the number of times a barrier change was associated with a Catastrophic leak

  3. Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool

    Time frame: through study completion, approximately 1 month

    QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OLI which is scored on a scale of 0-100 with higher scores indicating better outcomes

  4. Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool

    Time frame: through study completion, approximately 1 month

    QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OAI-23 which is scored on a scale of 0-92 with higher scores indicating better outcomes

  5. Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool

    Time frame: through study completion, approximately 1 month

    QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the SQS which is scored on a scale of 0-10 with higher scores indicating better outcomes

Other outcomes

  1. Whether and to what extent the LDS affected peristomal skin health, measured by the Ostomy Skin Tool 2.0 (OST 2.0) validated tool

    Time frame: starting at day 0, every 7 days, through day 28

    The Ostomy Skin Tool 2.0 (OST 2.0) validated tool will be used to evaluate and compare skin health before subjects use the LDS at the Day 0 Periodic assessment and every 7 days thereafter up to Day 28. The OST 2.0 is scored on a scale of 0-3 with higher scores indicating worse outcomes.

  2. Whether and to what extent the LDS affected healthcare resource utilization (HRU) and cost-effectiveness

    Time frame: through study completion, approximately 1 month

    Ostomy accessory usage, unplanned ostomy-related healthcare visits to a provider (such as a nurse or doctor, for example), incidence of and severity of PSCs (which have been shown to be associated with increased HRU), and/or wear (use) time of the ostomy barrier will be measured at periodic timepoints in the study (days 0, 7, 14, 21, 28, and/or 30) to obtain healthcare resource utilization (or cost) data which will be aggregated (summed) to evaluate the effect the LDS has on HRU and cost-effectiveness.

  3. To evaluate how satisfied users were with the alerts/notifications from the LDS

    Time frame: through study completion, approximately 1 month

    Satisfaction scores will be reported as the proportion of each response option on a 5-point scale, from very unsatisfied to very satisfied.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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