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Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
Pilot Study to Evaluate the Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications in Patients With New Ileostomies
1 other identifier
interventional
3
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing readmission rates of subjects with new ileostomies in the first 30 days post-operatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2019
CompletedResults Posted
Study results publicly available
March 19, 2020
CompletedMarch 19, 2020
March 1, 2020
1.6 years
February 25, 2016
February 19, 2020
March 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Readmission Rate
No outcomes were measured due to termination of study.
30 days post-operation
Study Arms (1)
Ostom-i device
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \>18 years of age
- English speaking
- creation of new ileostomy
- access to smartphone with bluetooth technology to support OIA application
- able to give written consent
- have preoperative counseling about stoma with ostomy nurse (excludes emergent ostomy creation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Messaris E, Sehgal R, Deiling S, Koltun WA, Stewart D, McKenna K, Poritz LS. Dehydration is the most common indication for readmission after diverting ileostomy creation. Dis Colon Rectum. 2012 Feb;55(2):175-80. doi: 10.1097/DCR.0b013e31823d0ec5.
PMID: 22228161BACKGROUNDNagle D, Pare T, Keenan E, Marcet K, Tizio S, Poylin V. Ileostomy pathway virtually eliminates readmissions for dehydration in new ostomates. Dis Colon Rectum. 2012 Dec;55(12):1266-72. doi: 10.1097/DCR.0b013e31827080c1.
PMID: 23135585BACKGROUND
Results Point of Contact
- Title
- Michael Seres
- Organization
- 11 Health
Study Officials
- PRINCIPAL INVESTIGATOR
Liliana Bordeianou, M.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery, Division of General and Gastrointestinal Surgery
Study Record Dates
First Submitted
February 25, 2016
First Posted
February 29, 2016
Study Start
August 1, 2017
Primary Completion
March 4, 2019
Study Completion
March 4, 2019
Last Updated
March 19, 2020
Results First Posted
March 19, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share