Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

NCT04880473 | Recruiting

• 1 other identifier: Entac-PrevisEA-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 8

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.

Conditions

Gastrointestinal Complication

Keywords

Postoperative ileus; Postoperative bowel obstruction; Emesis; Reversal of diet; Nasogastric tube; Abdominal sounds; Gastrointestinal impairment; Elective intestinal resection

Outcome Measures

Primary Outcomes (1)

• Performance of the PrevisEA device

  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.

  1-14 days

Secondary Outcomes (3)

• Positive predictive value (PPV)

  1-14 days

• Negative predictive value (NPV)

  1-14 days

• Overall percent agreement (OPA)

  1-14 days

Study Arms (1)

PrevisEA device

EXPERIMENTAL

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.

Device: PrevisEA device

Interventions

PrevisEA device 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. Under normal conditions, transformations of the data are visualized on the display. 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.

PrevisEA device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Allergies to any of the device components (i.e., adhesive)
• Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
• Patients undergoing:
• Small bowel resection without colonic resection
• Transanal proctectomy without transabdominal approach
• Perineal proctosigmoidectomy
• Closure of loop colostomy or ileostomy
• Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection

Sponsors & Collaborators

• Entac Medical Inc.: lead

Study Sites (8)

Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Spectrum Health Blodgett Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-1350, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Entac Medical Inc.

CONTACT

845-773-8473; previsea-001@clinicalresearchstrategies.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: September 14, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)