Previs Device for Intestinal Obstruction
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jennifer Hrabe
No Placebo Group
Approved in 1 jurisdiction
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.
12345Eligibility 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.
I am between 18 and 100 years old.
Exclusion Criteria
I cannot have a device attached to my stomach area due to certain conditions like fistulas or stomas.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Study ParticipantsExperimental Treatment3 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)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of IowaIowa City, IA
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Who is running the clinical trial?
Jennifer HrabeLead Sponsor
References
A prospective randomized trial of transnasal ileus tube vs nasogastric tube for adhesive small bowel obstruction. [2022]To study the therapeutic efficacy of a new transnasal ileus tube advanced endoscopically for adhesive small bowel obstruction.
[Wireless capsule endoscopy: basic principles and clinical utility]. [2019]Wireless capsule endoscopy (PillCam) represents a major advance in the study of small bowel disease since this procedure allows images of hitherto unreachable areas to be obtained. Approved for use by the Food and Drug Administration in August 2000, capsule endoscopy is currently a first line procedure in the study of small bowel disease. This technique consists of a non-reusable swallowable capsule (length 26 x 11 mm) that acquires video images while moving through the gastrointestinal tract propelled by natural peristalsis. The main indications of capsule endoscopy are evaluation of obscure gastrointestinal bleeding, chronic anemia, and inflammatory bowel disease. Contraindications are swallowing disorders and known or suspected small bowel strictures of any etiology. Consequently, small bowel follow through is useful prior to capsule endoscopy when these lesions are suspected.
Long-term safety of intraluminal spring-mediated bowel lengthening. [2023]The purpose of the study is to examine the long-term safety of an endoluminal bowel lengthening device prior to its use in the first human trial. In addition, device performance and natural passage will be evaluated.
Clinical impact of a newly developed capsule endoscope: usefulness of a real-time image viewer for gastric transit abnormality. [2022]A new capsule endoscope has been developed by Olympus Medical Systems. The visualization and usefulness of its real-time image viewer for gastric transit abnormality were evaluated by using this new device.
[Clinical use of endoscopic ileus tube drainage in preoperative therapy for acute low malignant colorectal obstruction]. [2006]To evaluate the clinical use of endoscopic ileus tube drainage in preoperative therapy for acute low malignant colorectal obstruction.