Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

March 11, 2024 updated by: Entac Medical Inc.

A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.

The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:
      • Rochester, Minnesota, United States, 55905
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-1350
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 90 years

  2. Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:

    1. Segmental ileocolic resection with or without diversion
    2. Segmental colon resection with or without diversion
    3. Segmental coloproctectomy with or without diversion
    4. Low anterior resection with or without diversion
    5. Abdominoperineal resection
    6. Total abdominal colectomy with or without diversion
    7. Proctocolectomy with or without end ileostomy or diversion
    8. Closure of end colostomy (Hartmann's reversal)

Exclusion Criteria:

  1. Allergies to any of the device components (i.e., adhesive)
  2. Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)

  3. Patients undergoing:

    1. Small bowel resection without colonic resection
    2. Transanal proctectomy without transabdominal approach
    3. Perineal proctosigmoidectomy
    4. Closure of loop colostomy or ileostomy
  4. Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrevisEA device
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
Device: PrevisEA device
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the PrevisEA device
Time Frame: 1-14 days
The performance (accuracy) of the device in predicting development of GII will be assessed through evaluation of the primary outcome measures of sensitivity and specificity for the device.
1-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value (PPV)
Time Frame: 1-14 days
Measures will be analyzed by using available data only
1-14 days
Negative predictive value (NPV)
Time Frame: 1-14 days
Measures will be analyzed by using available data only
1-14 days
Overall percent agreement (OPA)
Time Frame: 1-14 days
Measures will be analyzed by using available data only
1-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entac Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Entac-PrevisEA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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