Gastrointestinal ComplicationNCT04880473
Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
A study testing PrevisEA device in people with Gastrointestinal Complication, run by Entac Medical Inc. at 8 sites in United States.
Trial summary
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastrointestinal Complication
- What is being tested?
- PrevisEA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Sep 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 90 years
- Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
- Segmental ileocolic resection with or without diversion
- Segmental colon resection with or without diversion
- Segmental coloproctectomy with or without diversion
- Low anterior resection with or without diversion
Show all 10Show fewer
- Abdominoperineal resection
- Total abdominal colectomy with or without diversion
- Proctocolectomy with or without end ileostomy or diversion
- Closure of end colostomy (Hartmann's reversal)
Who cannot join
- Allergies to any of the device components (i.e., adhesive)
- Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
- Patients undergoing:
- Small bowel resection without colonic resection
- Transanal proctectomy without transabdominal approach
- Perineal proctosigmoidectomy
- Closure of loop colostomy or ileostomy
- Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1350
Paula Steele, paula_steele@med.unc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Rose Arrieta, rarrieta@northwestern.edu
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Rita Brienza, brienzr@ccf.org
- Recruiting
Spectrum Health Blodgett Hospital
Grand Rapids, Michigan, 49503
Hannah Wheeler, hannah.wheeler@corewellhealth.org
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Adeline Westman, westm128@umn.edu
- Recruiting
Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando
Orlando, Florida, 32803
Devonnae Sterling, devonnae.sterling@AdventHealth.com
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Charlie Borzy, borzyj@ohsu.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Yulia Nichols, potternichols.yulia@mayo.edu
About this study
Official title: A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.
The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
- Conditions
- Gastrointestinal Complication
- Being tested
- PrevisEA device
- Keywords
- Postoperative ileus, Postoperative bowel obstruction, Emesis, Reversal of diet, Nasogastric tube, Abdominal sounds, Gastrointestinal impairment, Elective intestinal resection
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevisEA deviceDevice
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
| Study group | Role | What they receive |
|---|---|---|
| PrevisEA device | Experimental | The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants. Receives: Device: PrevisEA device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the PrevisEA device
The performance (accuracy) of the device in predicting development of GII will be assessed through evaluation of the primary outcome measures of sensitivity and specificity for the device.
Measured: 1-14 days
Secondary outcomes (3)
Positive predictive value (PPV)
Measures will be analyzed by using available data only
Measured: 1-14 days
Negative predictive value (NPV)
Measures will be analyzed by using available data only
Measured: 1-14 days
Overall percent agreement (OPA)
Measures will be analyzed by using available data only
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start14 Sep 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplicationStudies 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entac Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880473
- Sponsor's protocol ID
- Entac-PrevisEA-001
- Status last verified
- Mar 2024
- First submitted
- 4 May 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
- ClinicalTrials.gov ID
- NCT04880473
- Acronym / sponsor ID
- Entac-PrevisEA-001
- Conditions
- Gastrointestinal Complication
- Keywords
- Postoperative ileus, Postoperative bowel obstruction, Emesis, Reversal of diet, Nasogastric tube, Abdominal sounds, Gastrointestinal impairment, Elective intestinal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Entac Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.
The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrevisEA device | Experimental | Device: PrevisEA deviceThe PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 and ≤ 90 years
- Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
Key exclusion criteria (8 listed)
- Allergies to any of the device components (i.e., adhesive)
- Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
- Patients undergoing:
- Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
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 |
|---|---|---|
| PrevisEA deviceThe PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants. | Device | PrevisEA device |
Primary outcome
Performance of the PrevisEA device
Time frame: 1-14 days
The performance (accuracy) of the device in predicting development of GII will be assessed through evaluation of the primary outcome measures of sensitivity and specificity for the device.
3 secondary outcomes
Positive predictive value (PPV)
Time frame: 1-14 days
Negative predictive value (NPV)
Time frame: 1-14 days
Overall percent agreement (OPA)
Time frame: 1-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrevisEA device in people with Gastrointestinal Complication, run by Entac Medical Inc. at 8 sites 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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Entac Medical Inc. (845-773-8473, previsea-001@clinicalresearchstrategies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the PrevisEA device (time frame: 1-14 days). 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 Mar 2024.