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Ostom-i Alert Sensor Quality of Life Validation

Stanford University logo

Stanford University

Status

Unknown

Conditions

Ostomy

Treatments

Device: Ostom-i Alert Sensor

Study type

Observational

Funder types

Other

Identifiers

NCT02319434
IRB-32211

Details and patient eligibility

About

The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.

Full description

Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse).

An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-80 years of age
  • use of an ostomy bag for at least six months
  • must own an iPhone, iPod Touch, or Android

Exclusion criteria

  • use of large urostomy bags

Trial contacts and locations

1

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Central trial contact

Dara Rouholiman, BS

Data sourced from clinicaltrials.gov

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