Recruiting

Ostom-i Alert Sensor

Sponsor:

Stanford University

Code:

NCT02319434

Conditions

Ostomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ostom-i Alert Sensor

Study Details

Brief summary:

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.

Conditions

Ostomy

Study ID

NCT02319434

Start date

Nov, 2015

Status verified date

Dec, 2018

Completion date

Mar 1, 2019

Anticipated

Primary completion date

Mar 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ostom-i Alert Sensor

Sensor on ostomy bag.

Primary outcome measure

  • Improved quality of life with any ostomy bag [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Dara Rouholiman, BS

6507236632darar@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Larry F Chu, MD

More Information

Sponsor

Stanford University

Last update posted

Dec 7, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2018-12-07.