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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05298774
Other study ID # 2000032548
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date September 1, 2024

Study information

Verified date April 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 team for management and potentially avoid preventable readmissions.


Description:

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Study Design


Intervention

Device:
G-tech WPS
G-tech WPS patches applied and activated within 4 hours of surgery

Locations

Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University G-Tech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary GI Functional Recovery Time to return of flatus or bowel movement after colorectal surgery 30 days after index surgery
Secondary Postoperative Ileus Occurrence of postoperative ileus after colorectal surgery 30 days after index surgery
Secondary Readmission with ileus Occurrence of readmission with postoperative ileus after colorectal surgery 30 days after index surgery
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