Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Complication

Intervention / Treatment
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* Device: PrevisEA device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 90 years Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for: Segmental ileocolic resection with or without diversion Segmental colon resection with or without diversion Segmental coloproctectomy with or without diversion Low anterior resection with or without diversion Abdominoperineal resection Total abdominal colectomy with or without diversion Proctocolectomy with or without end ileostomy or diversion Closure of end colostomy (Hartmann's reversal) Exclusion Criteria: Allergies to any of the device components (i.e., adhesive) Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.) Patients undergoing: Small bowel resection without colonic resection Transanal proctectomy without transabdominal approach Perineal proctosigmoidectomy Closure of loop colostomy or ileostomy Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrevisEA device<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the PrevisEA device | 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) | Measures will be analyzed by using available data only | 1-14 days | 
| Negative predictive value (NPV) | Measures will be analyzed by using available data only | 1-14 days | 
| Overall percent agreement (OPA) | Measures will be analyzed by using available data only | 1-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative ileus, Postoperative bowel obstruction, Emesis, Reversal of diet, Nasogastric tube, Abdominal sounds, Gastrointestinal impairment, Elective intestinal resection