Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Description

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.

Conditions

Gastrointestinal Complication

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Study Overview

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Study Details

Study overview

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.

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

Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Condition
Gastrointestinal Complication
Intervention / Treatment

-

Contacts and Locations

Orlando

Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando, Orlando, Florida, United States, 32803

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Grand Rapids

Spectrum Health Blodgett Hospital, Grand Rapids, Michigan, United States, 49503

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55414

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Chapel Hill

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599-1350

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Entac Medical Inc.,

Study Record Dates

2024-12-01