Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study

Status unconfirmed · Not applicable

Conditions studied: Ileostomy - Stoma, Ileostomy; Complications

In brief

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.

Key facts

Study ID

NCT03982875

Run by

11 Heath and Technologies Limited

People needed

100

Starts

2019-06-03

Expected to finish

2021-12-01

Last updated by the study team

2019-09-06

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Older than 22 years of age.
• Ability to communicate in spoken and written English.
• Ability to provide informed consent.
• Scheduled for colorectal surgery with creation of new ileostomy.
• Access to smartphone with bluetooth technology to support mobile and web application.

You may not qualify if…

• Pregnancy. Pregnancy test, standard of care, prior to surgery will be reviewed.
• Wearing electronic implants such as pacemakers.

Where it is running

• Cleveland Clinic, Department of Colorectal Surgery — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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