Optimizing the Previs Device for Prediction of Postoperative Ileus

NCT03505476 | Completed Results FDA Device

• 1 other identifier: 201801808
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus

Keywords

Ileus; Abdominal surgery; Bowel obstruction; Postoperative Ileus

Outcome Measures

Primary Outcomes (4)

• Device Sensitivity for Predicting Ileus.

  Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative).

  Each patient's device's data was assessed at day 15.

• Device Specificity for Predicting Ileus

  Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive).

  Each patient's device's data was assessed at day 15.

• Device Positive Predictive Value for Predicting Ileus

  Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive).

  Each patient's device's data was assessed at day 15.

• Device Negative Predictive Value for Predicting Ileus

  Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative).

  Each patient's device's data was assessed at day 15.

Study Arms (1)

Study Participants

EXPERIMENTAL

Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment

Device: Entac Medical device application; Other: Patient Daily Assessment; Other: Patient Discharge Assessment

Interventions

Entac Medical device application DEVICE

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.

Study Participants

Patient Daily Assessment OTHER

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.

Study Participants

Patient Discharge Assessment OTHER

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

Study Participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.
• Age 18 to 100.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jennifer Hrabe: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Ileus; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Jennifer Hrabe Clinical Associate Professor
• Organization: University of Iowa

jennifer-hrabe@uiowa.edu

319-384-7359

Study Officials

• Jennifer Hrabe

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: All subjects consented and enrolled will receive the same intervention. There is no control group.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 23, 2018
• Study Start: April 24, 2018
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: April 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)