Trial Outcomes & Findings for Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol (NCT NCT01697397)

Last Updated: 2025-09-30

Results Overview

All patients in the study received the investigational device for recording myoelectric signals. Patients had a variety of symptoms and diagnoses, among which the mean peak volume profiles for a group of subjects with gastroparesis (7 tests) and reflux disorder (9 tests) were identified and analyzed separately. Subjects were fed a 700 kCal meal 60 minutes into the test. Time-dependent peaks in the frequency spectra were identified and volumes (height x width x duration) were calculated from data obtained in 101 tests of FGID patients and controls. Peaks were associated with each of the digestive organs in frequency ranges as follows for stomach: 2-4 cycles per min. (cpm); small intestine: 5-12 cpm; and colon: 12-25 cpm. The patches measure the myoelectric voltage present at the skin surface to determine the motor activity of each organ. The unit of measure for the activity is (mV)\*\*2 X Hz. This is a standard measurement used in frequency spectrum analysis.

Recruitment status

COMPLETED

Target enrollment

88 participants

Primary outcome timeframe

Up to 4 hours at time of procedure

Results posted on

2025-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Device Arm 88 individuals were studied. Of the 88 individuals, 77 with FGID symptoms (constipation, diarrhea, pain, bloating) and 11 nominally healthy controls were studied. Data from the subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum presumably due to motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour.
Overall Study STARTED	88
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Device Arm n=88 Participants 88 individuals participated in this study. Data from all the subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum presumably due to motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour.
Age, Continuous	48.9 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race/Ethnicity, Customized Race - Asian	6 participants n=5 Participants
Race/Ethnicity, Customized Race - Caucasian	68 participants n=5 Participants
Race/Ethnicity, Customized Race - Hispanic or Latino	14 participants n=5 Participants
Region of Enrollment United States	88 participants n=5 Participants
Number of Participants with FGID symptoms and those who denied having FGID symptoms FGID Symptoms present	77 Participants n=5 Participants
Number of Participants with FGID symptoms and those who denied having FGID symptoms FGID symptoms absent (healthy controls)	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 hours at time of procedure

Outcome measures

Outcome measures
Measure	Individuals Without FGID Symptoms (Healthy Controls) n=88 Participants 11 individuals who denied FGID symptoms served as healthy controls	Individuals With Gastroparesis Among the subjects with FGIDs, there were 7 tests conducted with individuals diagnosed with gastroparesis.	Individuals With Reflux Disorder 9 individuals were studied having been diagnosed with a reflux disorder	Individuals With Bloating 12 Individuals studied were diagnosed with bloating.	Individuals With Constipation 30 individuals studied were diagnosed with constipation.	Individuals With Diarrhea 18 individuals studies were diagnosed with diarrhea.
Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.	88 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 hours at time of procedure

Population: Among the subjects studied, a sub group of subjects reported having gastroparesis and reflux disorders. These subjects were analyzed as separate groups and compared to the subjects who denied having any gastrointestinal disorders.

The study was not powered to analyze the differences for the FGID conditions of constipation and diarrhea, but was for a group of subjects with gastroparesis and reflux disorder. For these two groups, the mean myoelectrical activity in the stomach, small intestine, and colon were calculated and compared to that of the health controls.

Outcome measures

Outcome measures
Measure	Individuals Without FGID Symptoms (Healthy Controls) n=11 Participants 11 individuals who denied FGID symptoms served as healthy controls	Individuals With Gastroparesis n=7 Participants Among the subjects with FGIDs, there were 7 tests conducted with individuals diagnosed with gastroparesis.	Individuals With Reflux Disorder n=10 Participants 9 individuals were studied having been diagnosed with a reflux disorder	Individuals With Bloating n=12 Participants 12 Individuals studied were diagnosed with bloating.	Individuals With Constipation n=30 Participants 30 individuals studied were diagnosed with constipation.	Individuals With Diarrhea n=18 Participants 18 individuals studies were diagnosed with diarrhea.
Secondary Efficacy Outcome Stomach Preprandial myoelectrical activity	2.14 (mV)^2 x Hz Standard Deviation 1.27	0.75 (mV)^2 x Hz Standard Deviation 0.82	0.78 (mV)^2 x Hz Standard Deviation 0.61	1.24 (mV)^2 x Hz Standard Deviation 1.56	1.89 (mV)^2 x Hz Standard Deviation 1.88	1.61 (mV)^2 x Hz Standard Deviation 1.62
Secondary Efficacy Outcome Stomach Postprandial myoelectrical activity 1st hr	4.75 (mV)^2 x Hz Standard Deviation 2.82	1.54 (mV)^2 x Hz Standard Deviation 0.86	5.16 (mV)^2 x Hz Standard Deviation 4.90	5.02 (mV)^2 x Hz Standard Deviation 5.68	8.62 (mV)^2 x Hz Standard Deviation 15.67	3.53 (mV)^2 x Hz Standard Deviation 2.79
Secondary Efficacy Outcome Stomach Postprandial myoelectrical activity 2nd hr	7.39 (mV)^2 x Hz Standard Deviation 8.00	1.57 (mV)^2 x Hz Standard Deviation 0.87	11.41 (mV)^2 x Hz Standard Deviation 20.70	9.29 (mV)^2 x Hz Standard Deviation 17.40	7.19 (mV)^2 x Hz Standard Deviation 5.75	3.91 (mV)^2 x Hz Standard Deviation 3.06
Secondary Efficacy Outcome Intestine Preprandial myoelectrical activity	16.27 (mV)^2 x Hz Standard Deviation 15.16	7.68 (mV)^2 x Hz Standard Deviation 6.09	10.24 (mV)^2 x Hz Standard Deviation 8.67	12.04 (mV)^2 x Hz Standard Deviation 9.39	11.49 (mV)^2 x Hz Standard Deviation 6.72	14.55 (mV)^2 x Hz Standard Deviation 9.94
Secondary Efficacy Outcome Intestine Postprandial myoelectrical activity 2nd hr	20.18 (mV)^2 x Hz Standard Deviation 10.49	10.03 (mV)^2 x Hz Standard Deviation 8.54	15.28 (mV)^2 x Hz Standard Deviation 6.88	20.76 (mV)^2 x Hz Standard Deviation 11.42	14.33 (mV)^2 x Hz Standard Deviation 7.42	19.17 (mV)^2 x Hz Standard Deviation 15.49
Secondary Efficacy Outcome Colon Preprandial myoelectrical activity	3.32 (mV)^2 x Hz Standard Deviation 3.81	4.39 (mV)^2 x Hz Standard Deviation 4.05	8.60 (mV)^2 x Hz Standard Deviation 14.54	9.24 (mV)^2 x Hz Standard Deviation 11.91	7.50 (mV)^2 x Hz Standard Deviation 8.98	6.43 (mV)^2 x Hz Standard Deviation 7.25
Secondary Efficacy Outcome Colon Postprandial myoelectrical activity 1st hr	5.25 (mV)^2 x Hz Standard Deviation 2.42	11.83 (mV)^2 x Hz Standard Deviation 12.43	3.98 (mV)^2 x Hz Standard Deviation 4.02	4.49 (mV)^2 x Hz Standard Deviation 2.76	5.01 (mV)^2 x Hz Standard Deviation 6.24	10.68 (mV)^2 x Hz Standard Deviation 13.78
Secondary Efficacy Outcome Colon Postprandial myoelectrical activity 2nd hr	7.24 (mV)^2 x Hz Standard Deviation 4.26	9.26 (mV)^2 x Hz Standard Deviation 6.60	3.81 (mV)^2 x Hz Standard Deviation 2.80	8.20 (mV)^2 x Hz Standard Deviation 4.84	8.28 (mV)^2 x Hz Standard Deviation 9.28	7.39 (mV)^2 x Hz Standard Deviation 9.07
Secondary Efficacy Outcome Intestine Postprandial myoelectrical activity 1st hr	24.46 (mV)^2 x Hz Standard Deviation 11.55	9.38 (mV)^2 x Hz Standard Deviation 5.94	16.36 (mV)^2 x Hz Standard Deviation 8.78	24.01 (mV)^2 x Hz Standard Deviation 15.06	16.87 (mV)^2 x Hz Standard Deviation 8.11	21.79 (mV)^2 x Hz Standard Deviation 14.80

SECONDARY outcome

Timeframe: Up to 4 hours at time of procedure

Assess and record anticipated adverse events (AEs), unanticipated adverse device effects (UADEs), and serious adverse events (SAEs) at time of recording

Outcome measures

Outcome measures
Measure	Individuals Without FGID Symptoms (Healthy Controls) n=88 Participants 11 individuals who denied FGID symptoms served as healthy controls	Individuals With Gastroparesis Among the subjects with FGIDs, there were 7 tests conducted with individuals diagnosed with gastroparesis.	Individuals With Reflux Disorder 9 individuals were studied having been diagnosed with a reflux disorder	Individuals With Bloating 12 Individuals studied were diagnosed with bloating.	Individuals With Constipation 30 individuals studied were diagnosed with constipation.	Individuals With Diarrhea 18 individuals studies were diagnosed with diarrhea.
Number of Anticipated, Un-Anticipated, and Serious Adverse Events	0 adverse events	—	—	—	—	—

Adverse Events

Investigational Device Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steve Axelrod, PhD, CEO

G-Tech Medical

Phone: 650-269-1479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place