Clinical trial NCT04880473: Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
Official title: A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Complication
Keywords: Postoperative ileus
Postoperative bowel obstruction
Emesis
Reversal of diet
Nasogastric tube
Abdominal sounds
Gastrointestinal impairment
Elective intestinal resection
Lead sponsor: Entac Medical Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance of the PrevisEA device
timeFrame: 1-14 days
Secondary outcomes:
measure: Positive predictive value (PPV)
timeFrame: 1-14 days
measure: Negative predictive value (NPV)
timeFrame: 1-14 days
measure: Overall percent agreement (OPA)
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health Blodgett Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References: