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NCT05298774 · ClinicalTrials.gov registry record · NA
Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 77
- Enrollment target
NCT05298774 is a NA study that has completed, run by Yale University. The registered enrollment target is 77 participants.
The verdict
NCT05298774, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them. These pilot prospective, open clinical studies suggests that myoelectrical activity, measured on the abdominal surface with a noninvasive wireless patch system, carries predictive value in determining time to feeding and time to flatus following open abdominal surgery. Having such information in advance of clinical measures could facilitate timely interventions, be it early feeding or delaying feeding as dictated by the patient's unique recovery profile. The G-Tech Wireless Patch System would provide a unique insight into the process allowing for a tailored protocol that could improve patient satisfaction and optimize recovery. The system could also enable feedback on the impact to the overall gastrointestinal myoelectrical activity of medications, particularly opioids, used for pain management that are known to inhibit gastrointestinal function by disrupting the normal recovery patterns of colonic motility.23-25 While it remains to be seen, in addition to predicting time to flatus/bowel movement early on, the ability to continue monitoring the patient may allow one to predict onset of secondary complications, such as wound infections or anastomotic leaks, that are associated with ileus. Similarly, given the wireless noninvasive nature of the system the patients could be discharged home with the patches, whereby they would serve as a remote monitoring tool. This could be particularly useful in cases where the patients may have been discharged early and may be at a high risk for readmission. The system would then send updates/alerts to the care te
Interventions
- DEVICE G-tech WPS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2024-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05298774
The ClinicalTrials.gov registry entry for NCT05298774 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which G-tech WPS is the first listed.
NCT05298774 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05298774 about?
NCT05298774 is a clinical study titled "Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function". The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studie...
What is the current status of trial NCT05298774?
This trial is currently completed. It is a NA study. The enrollment target is 77 participants. The study started on 2022-06-01. Estimated completion is 2024-09-01.
What interventions are being tested in trial NCT05298774?
The interventions under investigation include: G-tech WPS (DEVICE).
Who is sponsoring clinical trial NCT05298774?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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