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SmartBag arm for Ileostomy

N/A

Waitlist Available

Led By Emre Gorgun, MD

Research Sponsored by 11 Heath and Technologies Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 60 and 90 days

Awards & highlights

No Placebo-Only Group

Summary

In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system. The system encompasses a pouch, a baseplate that can track the volumetric filling of the pouch through integrated thermistor and capacitive sensors and potential leakage and skin irritation development through integrated thermistors in the wafer. While patients with ileostomy have a risk of dehydration, early identification of those at greater risk may lead to home intervention and decreasing hospital readmission. Decreased readmissions ultimately leads to faster post-operative recovery, decreased risk of complications associated with readmissions (e.i. nosocomial infection, pneumonia, etc.) and decreased healthcare costs. Also evaluating the patients for possible stoma related complications in real time will help in treating them in a timely manner.

Eligible Conditions

Ileostomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 60 and 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30, 60 and 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60 and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Unplanned hospital readmission within 30 days of surgery

Secondary study objectives

Emergency department visits within 30, 60 and 90 days of surgery

Hydration Clinic visits within 30, 60 and 90 days of surgery

Number of clinically significant dehydration events within 30, 60 and 90 days of surgery

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SmartBag armExperimental Treatment1 Intervention

The Alfred SmartBag System will be placed on the ostomy site during surgery. The system will be used to wirelessly monitor ostomy function in the hospital setting and the patient will otherwise receive the standard of care. At discharge the patient will continue to use the Alfred SmartBag System and ostomy function will be monitored by the research and clinical teams remotely. If participant's output is (i) less than 50mL or greater than 1500mL per day or (ii) greater than 1200mL in two days; the mobile app will alert not only the participant but also the clinical staff (nurse). Participants will also receive support from a 'Patient Coach', a trained health coach who is also an ostomy patient to provide quality of life support.

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