IleusNCT03505476
Optimizing the Previs Device for Prediction of Postoperative Ileus
A study testing Entac Medical device application, Patient Daily Assessment and Patient Discharge Assessment in people with Ileus, run by Jennifer Hrabe at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ileus
- What is being tested?
- Entac Medical device application, Patient Daily Assessment and Patient Discharge Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.
- Age 18 to 100.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Ileus
- Being tested
- Entac Medical device application, Patient Daily Assessment, Patient Discharge Assessment
- Keywords
- Ileus, Abdominal surgery, Bowel obstruction, Postoperative Ileus
- Medical subject headings
- Ileus, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entac Medical device applicationDevice
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 AssessmentOther
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 AssessmentOther
The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment Receives: Device: Entac Medical device application; Other: Patient Daily Assessment; Other: Patient Discharge Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Each patient's device's data was assessed at day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start24 Apr 2018
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects consented and enrolled will receive the same intervention. There is no control group.
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Hrabe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Hrabe, University of Iowa
- Investigators
- Jennifer Hrabe, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505476
- Sponsor's protocol ID
- 201801808
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2018
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Previs Device for Prediction of Postoperative Ileus
- ClinicalTrials.gov ID
- NCT03505476
- Acronym / sponsor ID
- 201801808
- Conditions
- Ileus
- Keywords
- Ileus, Abdominal surgery, Bowel obstruction, Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Jennifer HrabeUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects consented and enrolled will receive the same intervention. There is no control group.
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Device: Entac Medical device application, Other: Patient Daily Assessment, Other: Patient Discharge AssessmentDevice: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.
- Age 18 to 100.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entac Medical device applicationSubjects 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. | Device | Study Participants |
| Patient Daily AssessmentThe 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. | Other | Study Participants |
| Patient Discharge AssessmentThe research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen. | Other | Study Participants |
Primary outcome
Device Sensitivity for Predicting Ileus.
Time frame: 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).
Device Specificity for Predicting Ileus
Time frame: 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).
Device Positive Predictive Value for Predicting Ileus
Time frame: 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).
Device Negative Predictive Value for Predicting Ileus
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hrabe principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entac Medical device application, Patient Daily Assessment and Patient Discharge Assessment in people with Ileus, run by Jennifer Hrabe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Sensitivity for Predicting Ileus. (time frame: Each patient's device's data was assessed at day 15.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.