Recruiting

PrevisEA Device

Sponsor:

Entac Medical Inc.

Code:

NCT04880473

Conditions

Gastrointestinal Complication

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PrevisEA device

Study Details

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

Study ID

NCT04880473

Start date

Sep 14, 2021

Status verified date

Mar, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Performance of the PrevisEA device [ Time Frame: 1-14 days ]

Central Contacts and Locations

Central contacts

Entac Medical Inc.

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

Locations

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

Recruiting

Orlando, Florida, United States, 32803

Contacts

Devonnae Sterling

devonnae.sterling@AdventHealth.com

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Rose Arrieta

rarrieta@northwestern.edu

Spectrum Health Blodgett Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Hannah Wheeler

hannah.wheeler@corewellhealth.org

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Adeline Westman

westm128@umn.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Yulia Nichols

potternichols.yulia@mayo.edu

The University of North Carolina at Chapel Hill

Recruiting

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

Contacts

Paula Steele

paula_steele@med.unc.edu

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rita Brienza

brienzr@ccf.org

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Charlie Borzy

borzyj@ohsu.edu

More Information

Sponsor

Entac Medical Inc.

Last update posted

Mar 13, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Entac Medical Inc. on 2024-03-13.