Evaluation of an Ostomy Leakage Detection System
NCT Number: NCT06547905
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ostomy
Interventions: DEVICE: Ostomy Leakage Detection System
Sponsor: Hollister Incorporated
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-24
Completion Date: 2024-12
Locations: PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park, Cambridge, Cambridgeshire, CB21 6GQ, United Kingdom

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

Primary Outcome Measures: 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
Secondary Outcome Measures: 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), 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
Other Outcome Measures: 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., 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