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

NCT03982875 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-06

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • 11 Heath and Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Emre Gorgun, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-09-01
Completion
2021-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982875 on ClinicalTrials.gov