Trial Outcomes & Findings for Optimizing the Previs Device for Prediction of Postoperative Ileus (NCT NCT03505476)
NCT ID: NCT03505476
Last Updated: 2025-04-13
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
Each patient's device's data was assessed at day 15.
Results posted on
2025-04-13
Participant Flow
Participant milestones
| Measure |
Study Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Overall Study
STARTED
|
203
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
128
|
Reasons for withdrawal
| Measure |
Study Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Overall Study
Physician Decision
|
18
|
|
Overall Study
Device Malfunctioned
|
101
|
|
Overall Study
Data Corrupt
|
6
|
|
Overall Study
Device application insufficiant
|
3
|
Baseline Characteristics
Optimizing the Previs Device for Prediction of Postoperative Ileus
Baseline characteristics by cohort
| Measure |
Study Participants
n=203 Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Each patient's device's data was assessed at day 15.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).
Outcome measures
| Measure |
Study Participants
n=75 Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: 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.
Patients with Ileus whose device predicted ileus (true positive).
|
12 Participants
|
|
Device Sensitivity for Predicting Ileus.
Patients with ileus whose device did not predict ileus (false negative).
|
2 Participants
|
|
Device Sensitivity for Predicting Ileus.
Patients without ileus whose device predicted ileus (false positive).
|
22 Participants
|
|
Device Sensitivity for Predicting Ileus.
Patients without ileus whose device did not predict ileus (true negative).
|
39 Participants
|
PRIMARY outcome
Timeframe: Each patient's device's data was assessed at day 15.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).
Outcome measures
| Measure |
Study Participants
n=75 Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Device Specificity for Predicting Ileus
Patients with ileus whose device predicted ileus (true positive)
|
12 Participants
|
|
Device Specificity for Predicting Ileus
Patients with ileus whose device did not predict ileus (false negative)
|
2 Participants
|
|
Device Specificity for Predicting Ileus
Patients without ileus whose device predicted ileus (false positive)
|
22 Participants
|
|
Device Specificity for Predicting Ileus
Patients without ileus whose device did not predict ileus (true negative)
|
39 Participants
|
PRIMARY outcome
Timeframe: Each patient's device's data was assessed at day 15.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).
Outcome measures
| Measure |
Study Participants
n=75 Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Device Positive Predictive Value for Predicting Ileus
Patients with ileus whose device did not predict ileus (false negative)
|
2 Participants
|
|
Device Positive Predictive Value for Predicting Ileus
Patients without ileus whose device predicted ileus (false positive)
|
22 Participants
|
|
Device Positive Predictive Value for Predicting Ileus
Patients without ileus whose device did not predicted ileus (true negative)
|
39 Participants
|
|
Device Positive Predictive Value for Predicting Ileus
Patients with ileus whose device predicted ileus (true positive)
|
12 Participants
|
PRIMARY outcome
Timeframe: Each patient's device's data was assessed at day 15.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).
Outcome measures
| Measure |
Study Participants
n=75 Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Entac Medical device application: 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.
Patient Daily Assessment: 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.
Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
|
|---|---|
|
Device Negative Predictive Value for Predicting Ileus
Patients with ileus whose device predicted ileus (true positive)
|
12 Participants
|
|
Device Negative Predictive Value for Predicting Ileus
Patients with ileus whose device did not predict ileus (false negative)
|
2 Participants
|
|
Device Negative Predictive Value for Predicting Ileus
Patients without ileus whose device predicted ileus (false positive)
|
22 Participants
|
|
Device Negative Predictive Value for Predicting Ileus
Patients without ileus whose device did not predicted ileus (true negative)
|
39 Participants
|
Adverse Events
Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Hrabe Clinical Associate Professor
University of Iowa
Phone: 319-384-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place