Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Not Applicable

Recruiting

• Conditions: Gastrointestinal Complication
• Interventions: Device: PrevisEA device

• Registration Number: NCT04880473
• Lead Sponsor: Entac Medical Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-10
• Study Start: 2021-09-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrevisEA 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. 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.

Primary Outcome Measures

Name	Time	Method
Performance of the PrevisEA device	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.

Secondary Outcome Measures

Name	Time	Method
Negative predictive value (NPV)	1-14 days	Measures will be analyzed by using available data only
Positive predictive value (PPV)	1-14 days	Measures will be analyzed by using available data only
Overall percent agreement (OPA)	1-14 days	Measures will be analyzed by using available data only

Trial Locations

Locations (8)

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Spectrum Health Blodgett Hospital; 🇺🇸 Grand Rapids, Michigan, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States