Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Entac Medical

Status: Enrolling

Conditions: Gastrointestinal Complication

Treatments: Device: PrevisEA device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04880473

Entac-PrevisEA-001

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

PrevisEA device

Experimental group

Description:

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.

Treatment:

Device: PrevisEA device