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

NCT03982875 | Unknown FDA Device

• 1 other identifier: 11HCCF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

remote monitoring; digital health; ostomy

Outcome Measures

Primary Outcomes (1)

• Unplanned hospital readmission within 30 days of surgery

  Unplanned hospital readmission will be determined from the hospital patient record. This will be checked by the research team on the 30th postoperative day.

  30 days

Secondary Outcomes (9)

• Unplanned hospital readmission within 60 and 90 days of surgery

  60 and 90 days

• The incidence of high or low output stoma (output <50ml for 1 day, output >1500ml for 1 day or for >1200ml for 2 consecutive days within 30, 60 and 90 days of surgery

  30, 60 and 90 days

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

  30, 60 and 90 days

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

  30, 60 and 90 days

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

  30, 60 and 90 days

Study Arms (1)

SmartBag arm

EXPERIMENTAL

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.

Device: Alfred SmartBag

Interventions

Alfred SmartBag DEVICE

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.

SmartBag arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• 11 Heath and Technologies Limited: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic, Department of Colorectal Surgery

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Emre Gorgun, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kavita Elliott

CONTACT

2164447493; Elliotk4@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 12, 2019
• Study Start: June 3, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)