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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No
View:

• 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)

Locations
United States
Florida
Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando
Recruiting
Orlando
Illinois
Northwestern University
Not yet recruiting
Evanston
Michigan
Spectrum Health Blodgett Hospital
Recruiting
Grand Rapids
Minnesota
University of Minnesota Medical Center
Recruiting
Minneapolis
Mayo Clinic
Recruiting
Rochester
North Carolina
The University of North Carolina at Chapel Hill
Recruiting
Chapel Hill
Ohio
The Cleveland Clinic Foundation
Suspended
Cleveland
Oregon
Oregon Health and Science University
Recruiting
Portland
Contact Information
Primary
Entac Medical Inc.
previsea-001@clinicalresearchstrategies.com
845-773-8473
Time Frame
Start Date: September 14, 2021
Estimated Completion Date: December 30, 2022
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Sponsors
Leads: Entac Medical Inc.

This content was sourced from clinicaltrials.gov

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