Trial Outcomes & Findings for Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications (NCT NCT02694757)

Last Updated: 2020-03-19

Results Overview

No outcomes were measured due to termination of study.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

30 days post-operation

Results posted on

2020-03-19

Participant milestones
Measure	Ostom-i Device Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application. Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Ostom-i Device Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application. Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device.
Overall Study Lack of Efficacy	3

Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications

Baseline characteristics by cohort
Measure	Ostom-i Device n=3 Participants Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application. Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 30 days post-operation

Population: No analysis was completed due to termination of study.

No outcomes were measured due to termination of study.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

11 Health

Phone: +16572660570