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This study will evaluate the safety and efficacy of an ostomy leakage detection system.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leakage Detection System arm | Experimental | Participants will utilize the leakage detection system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostomy Leakage Detection System | Device | A system that is used to detect ostomy leaks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Accuracy of the Leakage Detection System (LDS) | 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. | through study completion, approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| How adherent subjects are to leakage notifications (ratio) | The proportion of barriers that are changed due to accurate leakage notifications will yield insights into how adherent subjects are to leakage notifications. | through study completion, approximately 1 month |
| How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio) |
| Measure | Description | Time Frame |
|---|---|---|
| Whether and to what extent the LDS affected peristomal skin health, measured by the Ostomy Skin Tool 2.0 (OST 2.0) validated tool | 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. |
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:
b. Apple iPhones:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Hugill | Dansac | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park | Cambridge | Cambridgeshire | CB21 6GQ | United Kingdom |
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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 |
| through study completion, approximately 1 month |
| Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool | 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 | through study completion, approximately 1 month |
| Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool | 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 | through study completion, approximately 1 month |
| Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool | 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 | through study completion, approximately 1 month |
| starting at day 0, every 7 days, through day 28 |
| Whether and to what extent the LDS affected healthcare resource utilization (HRU) and cost-effectiveness | 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. | through study completion, approximately 1 month |
| To evaluate how satisfied users were with the alerts/notifications from the LDS | Satisfaction scores will be reported as the proportion of each response option on a 5-point scale, from very unsatisfied to very satisfied. | through study completion, approximately 1 month |