N/A
N=203
Optimizing the Previs Device for Prediction of Postoperative Ileus
Ileus
Bottom Line
View on ClinicalTrials.gov: NCT03505476 ↗Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Device Sensitivity for Predicting Ileus. — 12; 2; 22; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Entac Medical device application (Device); Patient Daily Assessment (Other); Patient Discharge Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jennifer Hrabe
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Sensitivity for Predicting Ileus. |
12; 2; 22; 39 | — |
| PRIMARY Device Specificity for Predicting Ileus |
12; 2; 22; 39 | — |
| PRIMARY Device Positive Predictive Value for Predicting Ileus |
12; 2; 22; 39 | — |
| PRIMARY Device Negative Predictive Value for Predicting Ileus |
12; 2; 22; 39 | — |
Summary
The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.
Eligibility Criteria
Inclusion Criteria
Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.
Age 18 to 100.
Exclusion Criteria
Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).
Data sourced from ClinicalTrials.gov (NCT03505476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.