Recruiting

Alfred SmartBag

Sponsor:

11 Heath and Technologies Limited

Code:

NCT03982875

Conditions

Ileostomy - Stoma

Ileostomy; Complications

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Alfred SmartBag

Study Details

Brief 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.

Conditions

Ileostomy - Stoma

Ileostomy; Complications

Study ID

NCT03982875

Start date

Jun 3, 2019

Status verified date

Sep, 2019

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Sep 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: SmartBag arm

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.

Interventions

Alfred SmartBag

The Alfred SmartBag encompasses a pouch, a baseplate, and a hub, is intended to be used as a continuous ostomy monitoring system by tracking 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. The Alfred SmartBag system is indicated for daily use for both in-patient and out-patient settings to provide information to patient and medical professionals. The data is intended to aid patient self-management and to alert the clinical team to changes in the patient condition that may warrant specific intervention.

Primary outcome measure

  • Unplanned hospital readmission within 30 days of surgery [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Kavita Elliott

2164447493Elliotk4@ccf.org

Locations

Cleveland Clinic, Department of Colorectal Surgery

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kavita Elliott

216-444-7493elliotk4@ccf.org

Principal Investigator:

Emre Gorgun, MD

More Information

Sponsor

11 Heath and Technologies Limited

Last update posted

Sep 6, 2019

Last verified

Sep, 2019

Keywords

  • remote monitoring
  • digital health
  • ostomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 11 Heath and Technologies Limited on 2019-09-06.