What is the mechanism of action of this treatment?

Common treatments for intestinal obstruction include non-surgical methods like nasogastric tube insertion to decompress the bowel, intravenous fluids to address dehydration and electrolyte imbalances, and medications for pain and nausea management. Surgical interventions may be required to remove the obstruction or repair damaged intestines. The noninvasive prototype device being studied aims to monitor and analyze intestinal sounds to predict postoperative ileus, which is crucial for early detection and management of obstructions. This approach can potentially reduce the need for invasive procedures, improving patient outcomes and recovery times.

What side effects are associated with this type of intervention?

Common treatments for intestinal obstruction include noninvasive methods such as nasogastric tube insertion, intravenous fluids, and bowel rest. These treatments generally have minimal side effects but can include discomfort from the nasogastric tube, dehydration, and electrolyte imbalances. Invasive treatments like surgery may be necessary in severe cases and carry risks such as infection, bleeding, and complications from anesthesia. Noninvasive monitoring techniques, like the prototype device for analyzing intestinal sounds, aim to predict and manage postoperative ileus with minimal risk, focusing on real-time, noninvasive assessment without significant adverse effects.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for noninvasive monitoring and analyzing intestinal sounds in the context of intestinal obstruction. Traditional treatments often involve surgical intervention, nasogastric decompression, and medications to manage symptoms. The development of noninvasive devices like the Previs Device represents a novel approach, focusing on real-time monitoring of intestinal sounds to predict and manage postoperative ileus, which could potentially improve patient outcomes and reduce the need for more invasive procedures.

What other types of research exist?

Promising novel alternatives for monitoring and diagnosing intestinal obstruction in 2024 include: 1) Wireless video capsule endoscopy, which allows for visualization of the entire small bowel without the need for invasive procedures, though it has limitations such as the inability to perform biopsies and risk of retention in strictures. 2) Ultrasound-based elastography, which measures tissue stiffness and can help detect abnormalities in the intestines. 3) Advanced CT and MR enterography, which provide detailed imaging of the intestinal wall and surrounding structures, aiding in the detection of obstructions and other abnormalities.

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Procedure

Previs Device for Intestinal Obstruction

N/A

Recruiting

Research Sponsored by Jennifer Hrabe

Eligibility Criteria Checklist

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

Must have

Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC

Age 18 to 100

Must not have

Inability to have prototype device applied to their abdominal wall due to a condition (e.g., fistulas, stomas, drains, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each patient's data will be evaluated after 14 days. each group of 10-30 patients' data will be analyzed. final analysis will occur after 225 patients are enrolled.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a small, wearable device that listens to stomach sounds in patients who had major abdominal surgery. It helps doctors know when it's safe for patients to start eating by analyzing intestinal sounds in real-time.

Who is the study for?

This trial is for adults aged 18 to 100 who are scheduled for elective intestinal resection surgery. They must be able to have a prototype device applied to their abdomen, so those with certain conditions like fistulas, stomas, or drains cannot participate.

What is being tested?

The study is testing the Previs Device which noninvasively records and analyzes intestinal sounds to predict postoperative ileus. Participants will use the device and complete daily assessments until discharge from the hospital.

What are the potential side effects?

Since this trial involves a noninvasive monitoring device rather than medication, traditional side effects are not expected. However, there may be discomfort or skin irritation where the device attaches to the abdominal wall.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for elective intestinal surgery by the colorectal team at UIHC.

Select...

I am between 18 and 100 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot have a device attached to my stomach area due to certain conditions like fistulas or stomas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each patient's data will be evaluated after 14 days. each group of 10-30 patients' data will be analyzed. final analysis will occur after 225 patients are enrolled.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each patient's data will be evaluated after 14 days. each group of 10-30 patients' data will be analyzed. final analysis will occur after 225 patients are enrolled.

This trial's timeline: 3 weeks for screening, Varies for treatment, and each patient's data will be evaluated after 14 days. each group of 10-30 patients' data will be analyzed. final analysis will occur after 225 patients are enrolled. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximize the predictive value of the device for predicting postoperative GI impairment.

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: Study ParticipantsExperimental Treatment3 Interventions

Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment

0 / 3Eligibility criteria met

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 intestinal obstruction include non-surgical methods like nasogastric tube insertion to decompress the bowel, intravenous fluids to address dehydration and electrolyte imbalances, and medications for pain and nausea management. Surgical interventions may be required to remove the obstruction or repair damaged intestines. The noninvasive prototype device being studied aims to monitor and analyze intestinal sounds to predict postoperative ileus, which is crucial for early detection and management of obstructions. This approach can potentially reduce the need for invasive procedures, improving patient outcomes and recovery times.

Real-time bowel sound analysis using newly developed device in patients undergoing gastric surgery for gastric tumor.