Previs Device for Intestinal Obstruction

Overseen By Debra OConnell Moore, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Hrabe

Disqualifiers: Allergies, Abdominal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Entac Medical device application (also known as PrevisEA), which listens to intestinal sounds to predict blockages and help doctors respond quickly. The goal is to ensure patients receive faster and more accurate care after intestinal surgery. The trial seeks individuals planning to undergo elective intestinal resection at a specific hospital. Participants should not have conditions like fistulas or stomas that would prevent device use. As an unphased trial, this study allows patients to contribute to innovative research that could enhance post-surgical care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Previs Device is safe for intestinal obstruction?

Research shows that the PrevisEA device is generally safe for use. It is noninvasive, meaning it doesn't involve surgery or breaking the skin. Instead, it listens to stomach sounds to help predict issues like intestinal blockages.

Clinical studies have tested this device, and participants reportedly tolerated it well. The information provided to the FDA supports its safety and effectiveness for its intended purpose. So far, studies have reported no major side effects.

Overall, the PrevisEA device appears to be a safe choice for those considering joining a trial that uses this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Entac Medical device for intestinal obstruction because it offers a novel approach to managing this condition. Unlike traditional treatments, which often involve surgical intervention to clear obstructions, this device is applied externally and aims to improve patient assessments and outcomes without invasive procedures. By focusing on non-invasive patient daily and discharge assessments, the Entac device could potentially reduce recovery times and hospital stays, making treatment more accessible and less burdensome for patients.

What evidence suggests that this device is effective for intestinal obstruction?

Research has shown that the PrevisEA device, used by participants in this trial, can predict stomach and intestinal problems by analyzing gut sounds. It employs special audio technology to assess these sounds and predict stomach health. The device is noninvasive, meaning it remains outside the body, ensuring comfort during use. It aids doctors in quickly determining the best care for patients with intestinal issues. Past studies suggest it effectively predicts and manages gut blockages. ^{2 3 6 7 8}

Who Is on the Research Team?

Jennifer Hrabe

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

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

Allergies to any of the device components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Application

Participants wear a 3-ounce device on the abdominal wall for 10 days to capture intestinal sounds

10 days

Daily in-hospital monitoring

Patient Daily Assessment

Participants answer daily questions regarding their tolerance to eating

10 days

Daily in-hospital assessment

Follow-up

Participants are monitored for safety and effectiveness after device application

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Entac Medical device application

Trial Overview 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.

How Is the Trial Designed?

Group I: Study Participants Experimental Treatment 3 Interventions

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

Entac Medical device application is already approved in United States for the following indications:

Approved in United States as PrevisEA for:

• Assessment of digestive health in patients following intestinal surgery
• Prediction of gastrointestinal impairment (GII)

Who Is Running the Clinical Trial?

Jennifer Hrabe

Lead Sponsor

Trials

1

Recruited

230+

Published Research Related to This Trial

The new capsule endoscope developed by Olympus Medical Systems effectively detected gastric transit abnormalities in 37 patients, demonstrating a diagnostic yield of 78%.

Administration of metoclopramide significantly increased gastric transit time (110 min vs. 24 min) while decreasing small bowel transit time (270 min vs. 347 min), indicating its role in managing gastric transit issues during capsule endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of a newly developed capsule endoscope: usefulness of a real-time image viewer for gastric transit abnormality. Ogata, H., Kumai, K., Imaeda, H., et al.[2022]

Endoscopic ileus tube drainage was successfully performed in 13 out of 15 patients with acute low malignant colorectal obstruction, demonstrating its effectiveness as a preoperative therapy.

The procedure led to a significant reduction in abdominal girth and relieved obstruction, which may enhance surgical outcomes by reducing colon edema and increasing the resection rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical use of endoscopic ileus tube drainage in preoperative therapy for acute low malignant colorectal obstruction]. Xu, JM., Zhong, YS., Xu, MD., et al.[2006]

Wireless capsule endoscopy (PillCam) is a significant advancement for examining small bowel diseases, providing images of areas that were previously difficult to access, and is now a first-line procedure since its FDA approval in 2000.

The main uses of capsule endoscopy include diagnosing obscure gastrointestinal bleeding, chronic anemia, and inflammatory bowel disease, but it is contraindicated in patients with swallowing disorders or suspected small bowel strictures, highlighting the importance of preliminary evaluations like small bowel follow-through.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Wireless capsule endoscopy: basic principles and clinical utility]. González-Suárez, B., Galter, S., Balanzó, J.[2019]

In a study of 186 patients with adhesive small bowel obstruction, the new transnasal ileus tube significantly reduced the time to relief of symptoms and improved abdominal radiograph findings compared to the traditional nasogastric tube, with an average of 4.1 days versus 8.5 days.

The ileus tube demonstrated a much higher overall effectiveness rate of 89.6% compared to 46.7% for the nasogastric tube, and it was also more effective in preventing the need for surgery in cases of recurrent obstruction (95.8% vs 31.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of transnasal ileus tube vs nasogastric tube for adhesive small bowel obstruction. Chen, XL., Ji, F., Lin, Q., et al.[2022]

The study demonstrated that the endoluminal bowel lengthening device was safe for long-term use in Yucatan minipigs, with no bowel obstructions or perforations observed during the 180-day evaluation period.

All devices successfully passed through the intestinal tract, and significant bowel lengthening was achieved without major complications, indicating the device's potential efficacy for future human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of intraluminal spring-mediated bowel lengthening. Rafeeqi, T., Sullins, VF., Thomas, AL., et al.[2023]

Citations

1. goodday.health goodday.health/trials/4880473

Entac-PrevisEA-001 - GoodDay PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal ...

2. entacmedical.com entacmedical.com/postoperative-ileus/

Postoperative Gastrointestinal Impairment Entac medical provides postoperative gastrointestinal impairment solutions to optimize post operative care pathway decisions that are affected by ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04880473

Evaluation of the PrevisEA Device for Predicting ... PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal ...

4. clinicaltrial.be clinicaltrial.be/en/details/44141?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluation of the PrevisEA Device for Predicting Gastroin... PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04880473?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Entac%20Medical%20Inc.%22)&viewType=Table&rank=1

Evaluation of the PrevisEA Device for Predicting ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

6. entacmedical.com entacmedical.com/wp-content/uploads/2022/07/PrevisEA-IFU.pdf

Instructions for Use The PrevisEA device is placed on the abdomen after abdominal surgery. • Take caution when placing the device to avoid directly placing the adhesive on top of ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K211068.pdf

August 4, 2021 Entac Medical Inc. Adam Harris Director ... The clinical data submitted validates the intended use of the PrevisEA Device. The nonclinical data support the safety and effectiveness of the ...

8. entacmedical.com entacmedical.com/qa/

Q&A PrevisEA is a wearable device that is used to assess digestive health immediately following surgery and days before gastrointestinal impairment (GII) due to ...