Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function

NCT05298774 | Completed Results FDA Device

• 1 other identifier: 2000032548
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Diseases; Ileus Paralytic; Ileus

Outcome Measures

Primary Outcomes (1)

• GI Functional Recovery

  Time to return of flatus or bowel movement after colorectal surgery

  30 days after index surgery

Secondary Outcomes (2)

• Postoperative Ileus

  30 days after index surgery

• Readmission With Ileus

  30 days after index surgery

Study Arms (1)

Postoperative recovery with G-tech WPS

EXPERIMENTAL

Device: G-tech WPS

Interventions

G-tech WPS DEVICE

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

Postoperative recovery with G-tech WPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Eighteen (18) years of age or older
• Subject is willing and able to follow all study requirements
• Subject has undergone or will undergo a laparoscopic or open colorectal surgery with resection and anastomosis

You may not qualify if:

• Subject is pregnant or suspects pregnancy.
• Known allergy to medical grade adhesive.

Sponsors & Collaborators

• Yale University: lead
• G-Tech Corporation: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Ileus

Condition Hierarchy (Ancestors)

Digestive System Diseases; Intestinal Obstruction; Intestinal Diseases

Limitations and Caveats

The study is limited by a short follow-up duration restricted to in-patient settings and aligning myoelectric readings with clinical symptoms is under-powered.

Results Point of Contact

• Title: Dr. Ira Leeds
• Organization: Yale University

ira.leeds@yale.edu

(203)785-2616

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)