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SmartBag arm for Ileostomy

N/A
Waitlist Available
Led By Emre Gorgun, MD
Research Sponsored by 11 Heath and Technologies Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60 and 90 days
Awards & highlights

Study Summary

Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study

Eligible Conditions
  • Ileostomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 60 and 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60 and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Unplanned hospital readmission within 30 days of surgery
Secondary outcome measures
Emergency department visits within 30, 60 and 90 days of surgery
Hydration Clinic visits within 30, 60 and 90 days of surgery
Number of clinically significant dehydration events within 30, 60 and 90 days of surgery
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SmartBag armExperimental Treatment1 Intervention
The Alfred SmartBag System will be placed on the ostomy site during surgery. The system will be used to wirelessly monitor ostomy function in the hospital setting and the patient will otherwise receive the standard of care. At discharge the patient will continue to use the Alfred SmartBag System and ostomy function will be monitored by the research and clinical teams remotely. If participant's output is (i) less than 50mL or greater than 1500mL per day or (ii) greater than 1200mL in two days; the mobile app will alert not only the participant but also the clinical staff (nurse). Participants will also receive support from a 'Patient Coach', a trained health coach who is also an ostomy patient to provide quality of life support.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER
1,030 Previous Clinical Trials
1,363,918 Total Patients Enrolled
11 Heath and Technologies LimitedLead Sponsor
1 Previous Clinical Trials
Emre Gorgun, MDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
71 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic, Department of Colorectal Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
2019. "Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03982875.
All > Tb
~17 spots leftby May 2025
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