NCT04880473 is a NA clinical trial of PrevisEA device in Gastrointestinal Complication, sponsored by Entac Medical Inc..

Who is sponsoring NCT04880473?

NCT04880473 is sponsored by Entac Medical Inc..

What drugs are being tested in NCT04880473?

Interventions in NCT04880473: PrevisEA device.

What condition does NCT04880473 study?

NCT04880473 studies Gastrointestinal Complication.

Is NCT04880473 still recruiting?

NCT04880473 is currently status unknown. Last updated 13 March 2024.

Last reviewed 2024-03-13 · How we verify

NCT04880473

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Status unknown NA Last updated 13 March 2024

What this trial tests

NA trial testing PrevisEA device in Gastrointestinal Complication in 400 participants. Status unknown.

Timeline

14 September 2021

Primary endpoint
1 September 2024

1 December 2024

Quick facts

Lead sponsor	Entac Medical Inc.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	400
Start date	14 September 2021
Primary completion	1 September 2024
Estimated completion	1 December 2024
Sites	8 locations across United States

Drugs / interventions tested

PrevisEA device

Conditions studied

Gastrointestinal Complication — all drugs for Gastrointestinal Complication →

Sponsor

Entac Medical Inc.

Who can join

Adults 18 to 90, any sex, with Gastrointestinal Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Gastrointestinal Complication

Currently open trials in the same condition.

NCT03848962 — Collection and Distribution of Biospecimens for Novel Research Uses · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04880473 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Entac Medical Inc.
Last refreshed: 13 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04880473.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing