Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimizing the Previs Device for Prediction of Postoperative Ileus

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: NCT03505476
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jennifer Hrabe, University of Iowa

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.

Condition or disease Intervention/treatment Phase
Ileus Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment Not Applicable

Detailed Description:

Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus

Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects consented and enrolled will receive the same intervention. There is no control group.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimizing the Previs Device for Prediction of Postoperative Ileus
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Study Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
 Device: Entac Medical device application
Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first.

Other: Patient Daily Assessment
The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized.

Other: Patient Discharge Assessment
The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximize the predictive value of the device for predicting postoperative GI impairment. [ Time Frame: Each patient's data will be evaluated after 14 days. Each group of 10-30 patients' data will be analyzed. Final analysis will occur after 225 patients are enrolled. ]
    The signal processing algorithm will be modified iteratively to maximize the negative predictive value of the device while maintaining the highest PPV The sensitivity, specificity, positive predictive value, negative predictive value, AUC, and accuracy of the device for each 10-30 patients (dependent upon the incidence of GI impairment in each group) will be measured. The signal processing algorithm will be modified iteratively to maximize the negative predictive value of the device while maintaining the highest PPV possible. Our goal is for the AUC for the final algorithm to be greater than 0.8.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.

Age 18 to 100.

Exclusion Criteria:

Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03505476


Contacts
Layout table for location contacts
Contact: Debra OConnell Moore, MBA 319-356-1693 debra-oconnell-moore@uiowa.edu
Contact: Jessica Danielson 319-356-1722 jessica-danielson@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jessica Danielson    319-356-1722    jessica-danielson@uiowa.edu   
Contact: Kimberly Sprenger    319-353-8862    kimberly-sprenger@uiowa.edu   
Sponsors and Collaborators
Jennifer Hrabe
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Hrabe University of Iowa
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jennifer Hrabe, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03505476    
Other Study ID Numbers: 201801808
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jennifer Hrabe, University of Iowa:
Ileus
Abdominal surgery
Bowel obstruction
Postoperative Ileus
Additional relevant MeSH terms:
Layout table for MeSH terms
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases