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

203 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the PrevisEA treatment for intestinal obstruction?

The research on transnasal ileus tubes and endoscopic ileus tube drainage suggests that similar devices can be effective in managing bowel obstructions by providing therapeutic relief. Additionally, capsule endoscopy, a related technology, has been shown to be useful in diagnosing and managing small bowel diseases, indicating potential benefits of using advanced devices in gastrointestinal conditions. ^{1 2 3 4 5}

Research Team

Jennifer Hrabe

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of transnasal ileus tube vs nasogastric tube for adhesive small bowel obstruction. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Wireless capsule endoscopy: basic principles and clinical utility]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term safety of intraluminal spring-mediated bowel lengthening. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Clinical impact of a newly developed capsule endoscope: usefulness of a real-time image viewer for gastric transit abnormality. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical use of endoscopic ileus tube drainage in preoperative therapy for acute low malignant colorectal obstruction]. [2006]