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Trial record 44 of 76 for:    Stoma Ileostomy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03982875
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
11 Heath and Technologies Limited

Brief Summary:

In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system. The system encompasses a pouch, a baseplate that can track the volumetric filling of the pouch through integrated thermistor and capacitive sensors and potential leakage and skin irritation development through integrated thermistors in the wafer.

While patients with ileostomy have a risk of dehydration, early identification of those at greater risk may lead to home intervention and decreasing hospital readmission. Decreased readmissions ultimately leads to faster post-operative recovery, decreased risk of complications associated with readmissions (e.i. nosocomial infection, pneumonia, etc.) and decreased healthcare costs. Also evaluating the patients for possible stoma related complications in real time will help in treating them in a timely manner.


Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Ileostomy; Complications Device: Alfred SmartBag Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SmartBag arm

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.

Device: Alfred SmartBag
The Alfred SmartBag encompasses a pouch, a baseplate, and a hub, is intended to be used as a continuous ostomy monitoring system by tracking the volumetric filling of the pouch through integrated thermistor and capacitive sensors and potential leakage and skin irritation development through integrated thermistors in the wafer. The Alfred SmartBag system is indicated for daily use for both in-patient and out-patient settings to provide information to patient and medical professionals. The data is intended to aid patient self-management and to alert the clinical team to changes in the patient condition that may warrant specific intervention.




Primary Outcome Measures :
  1. Unplanned hospital readmission within 30 days of surgery [ Time Frame: 30 days ]
    Unplanned hospital readmission will be determined from the hospital patient record. This will be checked by the research team on the 30th postoperative day.


Secondary Outcome Measures :
  1. Unplanned hospital readmission within 60 and 90 days of surgery [ Time Frame: 60 and 90 days ]
    Unplanned hospital readmission will be determined from the hospital patient record. This will be checked by the research team on the 60th and 90th postoperative day.

  2. The incidence of high or low output stoma (output <50ml for 1 day, output >1500ml for 1 day or for >1200ml for 2 consecutive days within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    The incidence of high or low output stoma will be determined from the Alfred SmartBag dashboard. A historical report will be analysed at 30, 60 and 90 days.

  3. Number of clinically significant dehydration events within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    Clinically significant dehydration events will be determined from the hospital patient record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  4. Emergency department visits within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    Emergency department visits will be determined from the hospital patient record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  5. Hydration Clinic visits within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    Hydration clinic visits will be determined from the hospital patient record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  6. Surgical Site Infection rates within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    Surgical Site Infection will be determined from the hospital patient record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  7. The incidence of patient-reported stoma accidents (leakage) within 30, 60 and 90 days of surgery [ Time Frame: 30, 60 and 90 days ]
    The incidence of patient-reported stoma accidents (leakage) will be determined by analysis of the Patient Coach record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  8. Patient reported satisfaction when using the Alfred SmartBag System [ Time Frame: 30, 60 and 90 days ]
    Patient reported satisfaction will be determined by thematic analysis of the Patient Coach record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.

  9. Patient reported quality of life when using the Alfred SmartBag System [ Time Frame: 30, 60 and 90 days ]
    Patient reported quality of life will be determined by thematic analysis of the Patient Coach record. This will be checked by the research team on the 30th, 60th and 90th postoperative day.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 22 years of age.
  • Ability to communicate in spoken and written English.
  • Ability to provide informed consent.
  • Scheduled for colorectal surgery with creation of new ileostomy.
  • Access to smartphone with bluetooth technology to support mobile and web application.

Exclusion Criteria:

  • Pregnancy. Pregnancy test, standard of care, prior to surgery will be reviewed.
  • Wearing electronic implants such as pacemakers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982875


Contacts
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Contact: Kavita Elliott 2164447493 Elliotk4@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Department of Colorectal Surgery Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kavita Elliott    216-444-7493    elliotk4@ccf.org   
Principal Investigator: Emre Gorgun, MD         
Sub-Investigator: Ipek Sapci, MD         
Sub-Investigator: Scott Steele, MD         
Sub-Investigator: Samuel Hinckley, PA         
Sub-Investigator: Hanna Horne, PA         
Sub-Investigator: Brogan Catalano, RN         
Sub-Investigator: Rachel Mathoslah, RN         
Sponsors and Collaborators
11 Heath and Technologies Limited
The Cleveland Clinic
Investigators
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Principal Investigator: Emre Gorgun, MD The Cleveland Clinic
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Responsible Party: 11 Heath and Technologies Limited
ClinicalTrials.gov Identifier: NCT03982875    
Other Study ID Numbers: 11HCCF
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by 11 Heath and Technologies Limited:
remote monitoring
digital health
ostomy