What side effects are associated with this type of intervention?

Common treatments for gastrointestinal complications like postoperative ileus (POI) include parenteral nutrition, probiotics, and supportive therapies. Parenteral nutrition can lead to complications such as infections, particularly when lipid solutions are used, and may increase the risk of infectious complications. Probiotics are generally safe but can cause systemic infections in immunocompromised patients and may be contaminated with allergens like cow's milk protein. Supportive therapies, including the use of proton pump inhibitors and glucocorticoids, can have side effects such as gastrointestinal upset, increased risk of infections, and potential for systemic complications.

What prior FDA approvals exist?

The FDA has approved various treatments for gastrointestinal complications, including medications and devices. For instance, medications like alvimopan (Entereg) are approved for accelerating the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection. Additionally, noninvasive devices such as the SmartPill, which measures pH, pressure, and temperature to assess gastrointestinal motility, have been approved. While specific FDA approvals for devices using audio spectral analysis like PrevisEA are not detailed, the focus remains on noninvasive methods to predict and manage postoperative gastrointestinal impairments.

What other types of research exist?

Promising novel alternatives to PrevisEA for gastrointestinal complications include: 1) Multispectral Optoacoustic Tomography (MSOT) for non-invasive imaging of disease activity, 2) Magnetic Resonance Enterography (MRE) for detailed imaging of the small bowel, and 3) Endoscopic Ultrasound (EUS) with elastography and contrast-enhanced ultrasound (CEUS) for enhanced visualization and assessment of gastrointestinal lesions.

← Back to Search

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

No Placebo-Only Group

Summary

This trial tests PrevisEA, a simple gadget that listens to stomach sounds, on patients having major abdominal surgery. It aims to predict if their digestion will have issues after the operation.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of the PrevisEA device

Secondary study objectives

Negative predictive value (NPV)

Overall percent agreement (OPA)

Positive predictive value (PPV)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastrointestinal complications include antibiotics, proton pump inhibitors, glucocorticoids, and biologic agents. Antibiotics work by targeting and eliminating bacterial infections, which is crucial for conditions like intra-abdominal infections. Proton pump inhibitors reduce stomach acid production, helping to manage symptoms of gastroduodenal Crohn disease. Glucocorticoids and biologic agents modulate the immune response, reducing inflammation and promoting healing in severe Crohn disease. These treatments are essential for managing symptoms, preventing complications, and improving the quality of life for patients. The PrevisEA device, which uses audio spectral analysis to predict gastrointestinal impairment, could complement these treatments by providing early detection and allowing timely intervention, potentially reducing the need for more invasive procedures.

Review Article: pain versus discomfort--is differentiation clinically useful?