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PrevisEA Device for Gastrointestinal Complications

N/A

Recruiting

Research Sponsored by Entac Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-14 days

Awards & highlights

Study Summary

This trial is being done to see if the PrevisEA can help predict GII in people who have had major abdominal surgery. The device is considered NSR, which means it's not likely to cause any harm. The results of the device will be unknown to the researchers during the study.

Who is the study for?

This trial is for adults aged 18 to 90 who are undergoing elective intestinal resection surgery, which can include various specific procedures. It's not for those with allergies to the device materials or certain preoperative conditions like infections or if they cannot have the device applied due to other medical issues.Check my eligibility

What is being tested?

The PrevisEA device is being tested; it's a noninvasive tool that listens to gut sounds to predict gastrointestinal impairment after abdominal surgery. The study will not use the device's data for medical decisions and researchers won't see the results during the trial.See study design

What are the potential side effects?

Since PrevisEA is a noninvasive monitoring device, significant side effects are not expected. However, some individuals might experience skin irritation from adhesive components of the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Performance of the PrevisEA device

Secondary outcome measures

Negative predictive value (NPV)

Overall percent agreement (OPA)

Positive predictive value (PPV)

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrevisEA deviceExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Entac Medical Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are my qualifications sufficient to be accepted into this clinical experiment?

"Currently, 400 individuals suffering from gastrointestinal issues of all ages between 18 and 90 are being recruited for the trial. To qualify, applicants must have had a segmental ileocolic resection with or without diversion; an abdominoperineal resection; a segmental colon resection with or without diversion; a segmental coloproctectomy with or without diversion; a low anterior resection with or without diversion; total abdominal colectomy with or without diversion; proctocolectomy with or without end ileostomy/diversion, as well as closure of end colostomy (Hartmann's reversal"

Answered by AI

Are there any vacancies remaining in this scientific exploration?

"Clinicaltrials.gov data indicates that this experiment, which was initially posted on September 14th 2021, is still enrolling participants. The trial's latest update occurred on July 26 of 2022."

Answered by AI

How widespread is the implementation of this experiment?

"At the moment, 10 medical centres are running this trial. Among them include Minneapolis, Grand Rapids and Orlando along with other sites. To curtail travel-related costs, we recommend selecting a facility close to you if you intend on taking part in the study."

Answered by AI

Does this trial accept participants above the age of 40?

"Consistent with the trial's guidelines, participants must be at least 18 years old and not exceed 90."

Answered by AI

What is the current enrollment size for this clinical trial?

"This trial necessitates 400 individuals meeting the designated inclusion criteria. These volunteers can be found at various sites such as University of Minnesota in Minneapolis and Spectrum Health System in Grand Rapids, Michigan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

2021. "Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880473.