An interventional study of Entac Medical device application and Patient Daily Assessment in Ileus, sponsored by Jennifer Hrabe. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Jennifer Hrabe · Not applicable, Interventional, and Diagnostic
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.
Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus
Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 203 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →This is the only study on the registry with Jennifer Hrabe as lead sponsor.
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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).
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Device: Entac Medical device application · Other: Patient Daily Assessment · Other: Patient Discharge Assessment
Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first.
The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized.
The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
Device Sensitivity for Predicting Ileus.
Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative).
Time frame: Each patient's device's data was assessed at day 15.
Device Specificity for Predicting Ileus
Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive).
Time frame: Each patient's device's data was assessed at day 15.
Device Positive Predictive Value for Predicting Ileus
Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive).
Time frame: Each patient's device's data was assessed at day 15.
Device Negative Predictive Value for Predicting Ileus
Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative).
Time frame: Each patient's device's data was assessed at day 15.
| Milestone | Study Participants |
|---|---|
| Started | 203 |
| Completed | 75 |
| Not completed | 128 |
| Withdrew: Physician decision | 18 |
| Withdrew: Device malfunctioned | 101 |
| Withdrew: Data corrupt | 6 |
| Withdrew: Device application insufficiant | 3 |
Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative).
| Participants | Study Participants |
|---|---|
| Patients with Ileus whose device predicted ileus (true positive). | 12 |
| Patients with ileus whose device did not predict ileus (false negative). | 2 |
| Patients without ileus whose device predicted ileus (false positive). | 22 |
| Patients without ileus whose device did not predict ileus (true negative). | 39 |
Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive).
| Participants | Study Participants |
|---|---|
| Patients with ileus whose device predicted ileus (true positive) | 12 |
| Patients with ileus whose device did not predict ileus (false negative) | 2 |
| Patients without ileus whose device predicted ileus (false positive) | 22 |
| Patients without ileus whose device did not predict ileus (true negative) | 39 |
Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive).
| Participants | Study Participants |
|---|---|
| Patients with ileus whose device predicted ileus (true positive) | 12 |
| Patients with ileus whose device did not predict ileus (false negative) | 2 |
| Patients without ileus whose device predicted ileus (false positive) | 22 |
| Patients without ileus whose device did not predicted ileus (true negative) | 39 |
Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative).
| Participants | Study Participants |
|---|---|
| Patients with ileus whose device predicted ileus (true positive) | 12 |
| Patients with ileus whose device did not predict ileus (false negative) | 2 |
| Patients without ileus whose device predicted ileus (false positive) | 22 |
| Patients without ileus whose device did not predicted ileus (true negative) | 39 |
Collected over Adverse event data was collected on all subjects until their study participation is completed. (typically at or around 14 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/203 (0%) | 0/203 (0%) | 0/203 (0%) |
| Age, Categorical(Participants) | Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 139 |
| >=65 years | 64 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 108 |
| Male | 95 |
| Ethnicity (NIH/OMB)(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 197 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 195 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Study Participants |
|---|---|
| United States | 203 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Jun 2023, 61 months.
Results were first posted in Apr 2025, 1 year 10 months after primary completion.
Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's 61 months is above that.
Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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