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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02472639
Other study ID # Pro00040251
Secondary ID
Status Terminated
Phase N/A
First received June 12, 2015
Last updated October 10, 2017
Start date June 10, 2015
Est. completion date May 26, 2016

Study information

Verified date October 2017
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.


Description:

Patients with ileostomy have impaired quality of life related to their ileostomy (Person et al. DCR. 2012; 55: 783 - 787; Scarpa et al. Colorectal Dis. 2010; 12: 914 - 920). Although patients with ileostomy have better overall quality of life compared with colostomy patients (Silva et al. Worl J Surg. 2003; 27: 421-424), the liquid nature of the ileostomy effluent predisposes these patients to bag overfilling and dehydration more so than colostomy patients (Paquette et al. DCR 2013; 56: 974-979). This may be specifically important in populations with long term or permanent ileostomy. Overfilling and breakage/leakage of the ileostomy bag can also affect patient's ability to function in social environments, go out in public, have intimate relationships with significant others, and interfere with sleep patterns (due to high output and nighttime overfilling of the ileostomy bag).

The Ostom-i Alert is a novel device developed by a patient with ileostomy and now FDA approved in the United States. The device is a sensor that clips onto any ostomy bag and sends a Bluetooth signal to a mobile device app. An alarm lets the patient know before the stoma bag is at risk for overfilling and leaking. The potential advantage is that the device can prevent unexpected bag overfilling, breakage, and nighttime accidents. This may therefore lead to improved quality of life. The volume and output recordings can also be stored and emailed to the patient's health care providers, with potential to reduce ostomy related dehydration through more accurate volume recording and sharing.

While the device has many applications, the purpose of this research study is to specifically evaluate patient quality of life after application of the Ostom-i Alert compared with standard ostomy care.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date May 26, 2016
Est. primary completion date May 26, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with ileostomies in place without a plan for ileostomy take down in the next 4 months.

2. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

3. Males or females, age 18 and older at the time of study screening;

4. Patients with loop or end ileostomy at least 1 month since ileostomy creation

5. No plan for stoma reversal for the next 4 months to allow adequate time for study inclusion

6. Patients who own an iPhone, iPod Touch, or Android device

Exclusion Criteria:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;

2. Children <18

3. Pregnant patients

4. Patients with planned ileostomy closure in the next 4 months

5. Patients with colostomy, more than one ostomy, or urostomy

6. Patients unable or unwilling to come in for in person Ostomi-I Alert teaching and screening visits

7. Patients without an iPhone, iPod Touch, or Android device

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ostom-i Alert Sensor
Wear the Ostom-i Alert Sensor
Other:
No Ostom-i Alert Sensor
Patient will not use device

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Quality of Life as Measured by the 20-item Stoma-QOL Questionnaire at 1 Month and 3 Month Follow-up After Using the Ostomi-I Alert Versus Standard Stoma Care Without the Ostom-i Alert. up to 3 Months
Secondary Overall Satisfaction With Ostom-i Device Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. 3 months
Secondary Number of Ostomy Bag Breakages During the Study Period Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. 3 months
Secondary Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. 3 months
Secondary Dehydration Related Hospital Admissions During Study Period Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. 3 months
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