Trial Outcomes & Findings for Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy (NCT NCT02472639)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

up to 3 Months

Results posted on

2017-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ostom-i Alert Sensor Patients will wear Ostom-i sensor Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor	No Ostom-i Alert Sensor Patient will not wear Ostom-i sensor No Ostom-i Alert Sensor: Patient will not use device
Overall Study STARTED	4	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ostom-i Alert Sensor Patients will wear Ostom-i sensor Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor	No Ostom-i Alert Sensor Patient will not wear Ostom-i sensor No Ostom-i Alert Sensor: Patient will not use device
Overall Study Physician Decision	4	3

Baseline Characteristics

Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: up to 3 Months

Population: Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.

Outcome measures

Outcome data not reported

Adverse Events

Ostom-i Alert Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Ostom-i Alert Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Zaghiyan, MD

Cedars Sinai Medical Center

Phone: 310-289-9224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place