Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Gastrointestinal Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880473
• Other study ID #: Entac-PrevisEA-001
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Entac Medical Inc.
• Contact: Entac Medical Inc.
• Phone: 845-773-8473
• Email: previsea-001[@]clinicalresearchstrategies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Complication

Intervention

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. 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.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Spectrum Health Blodgett Hospital	Grand Rapids	Michigan
United States	University of Minnesota	Minneapolis	Minnesota
United States	Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando	Orlando	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Entac Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Positive predictive value (PPV)	Measures will be analyzed by using available data only	1-14 days
Secondary	Negative predictive value (NPV)	Measures will be analyzed by using available data only	1-14 days
Secondary	Overall percent agreement (OPA)	Measures will be analyzed by using available data only	1-14 days