An observational study in Post-operative Ileus, sponsored by G-Tech Corporation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by G-Tech Corporation · Observational
This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.
While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 150 is close to the median of 159 across 26 observational studies indexed under Ileus.
Browse Ileus studies →G-Tech Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include candidates who undergo GI surgery or other surgery outside not involving the abdominal cavity, who agree to the application of the G-Tech Device to be placed on his/her abdomen and meet all eligibility criteria as defined. Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity or following. Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post-operatively during their hospital stay for this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity. The investigator does not change the routine medical care of study participants.
Device: G-Tech Myoelectric recording device
Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post- operatively during their hospital stay for this study.The investigator does not change the routine medical care of study participants.
Device: G-Tech Myoelectric recording device
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
Also known as: Gastro-intestinal electrical recording
Myoelectric activity pattern in POI patients versus non-POI patients
The resumption of motor activity in the stomach, small intestine, and colon post-operatively. The measurement is myoelectric signals measured at the skin surface similar to ECG recordings for the heart
Time frame: Up to 6 Days
Anticipated Adverse Events
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
Time frame: Up to 6 days
UADEs
Unanticipated adverse device effects
Time frame: Up to 6 Days
Device Success
Device success defined as the ability to record GI myoelectric activity following GI surgery.
Time frame: Up to 6 Days
Plan to share: No — Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.
The record gives a start of Feb 2016, a primary completion of Dec 2023 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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G-Tech Corporation