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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

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

Study Summary

This trial will develop a device to help predict when a patient will have a bowel movement, so that they can be better prepared for it.

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.Check my eligibility

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.See study design

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

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

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I am between 18 and 100 years old.

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

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

Primary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jennifer HrabeLead Sponsor

Media Library

Entac Medical device application (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03505476 — N/A

Intestinal Obstruction Research Study Groups: Study Participants

Intestinal Obstruction Clinical Trial 2023: Entac Medical device application Highlights & Side Effects. Trial Name: NCT03505476 — N/A

Entac Medical device application (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03505476 — N/A

Frequently Asked Questions

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

How many individuals are actively participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently in search of participants. It was first launched on April 24th 2018 and has been updated as recently as July 12th 2022. This trial requires 225 people over the course of 1 site."

Answered by AI

Does this trial permit applicants over twenty years of age?

"The medical trial is seeking participants aged 18 and under 100 years of age."

Answered by AI

Are there remaining vacancies for this clinical trial?

"Affirmative. Clinicaltrials.gov verifies that this medical experiment, which was first posted on April 24th 2018, is currently recruiting volunteers. Approximately 225 participants need to be found from 1 location."

Answered by AI

What are the eligibility requirements for participating in this research?

"To be eligible for this study, the patient must have ileus and lie between 18-100 years old. The trial is aiming to recruit around 225 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing the Previs Device for Prediction of Postoperative Ileus

Jennifer Hrabe 2018. "Optimizing the Previs Device for Prediction of Postoperative Ileus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03505476.