A Study of the Practicality and Usefulness of the Ostom-I Alert System with Pediatric Ostomy Patients

Overview

About this study

The purpose of this study is to understand the practicallity and usefulness of a new stoma monitoring device that alerts patients through Bluetooth how full their ostomy pouch is so they can empty it. Pediatric patients will try the Ostom-i Alert system and respond to periodic surveys about the effect on their quality of life.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria 

  • Age 2 to 17
  • Have or will get an enteric stoma (ileostomy or colostomy) between April 2016 – April 2017
  •  Must be able to download the associated mobile application (free of charge) onto their own smartphone or tablet device
  • Agree to wear the device for 3 months
  • Agree to complete surveys at 1 month intervals on the usefulness and practicality of the device

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Denise Klinkner, M.D., M.Ed.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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