Trial Outcomes & Findings for Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis (NCT NCT00595621)
NCT ID: NCT00595621
Last Updated: 2019-05-31
Results Overview
Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
12 Weeks
Results posted on
2019-05-31
Participant Flow
Diabetic gastroparetic patients who qualified to participate in this study based on inclusionary criteria were recruited from the Gastroenterology Motility Clinic of KUMC in Kansas City, KS
All subjects underwent an open-label phase where multi-channel gastric pacemaker (MGP-1) was turned "ON" for 6 weeks. After this phase they were randomized in double blind fashion to MGP-1 "ON" or "OFF" for another 4 weeks. 3 participants were not randomized to continue the study after the open-label phase.
Participant milestones
| Measure |
MGP-1 "ON"
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Open Label Run in
STARTED
|
22
|
0
|
|
Open Label Run in
COMPLETED
|
19
|
0
|
|
Open Label Run in
NOT COMPLETED
|
3
|
0
|
|
Randomization and Study
STARTED
|
10
|
9
|
|
Randomization and Study
COMPLETED
|
8
|
8
|
|
Randomization and Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
MGP-1 "ON"
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Open Label Run in
Adverse Event
|
1
|
0
|
|
Open Label Run in
Physician Decision
|
1
|
0
|
|
Open Label Run in
Withdrawal by Subject
|
1
|
0
|
|
Randomization and Study
Adverse Event
|
2
|
0
|
|
Randomization and Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Baseline characteristics by cohort
| Measure |
MGP-1 "ON"
n=10 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=9 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
n=5 Participants
|
40 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksParticipants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Percentage of Slow Wave Entrainment
Baseline Pre-Randomization Phase
|
72 percentage of slow waves entrainment
Standard Deviation 3
|
70 percentage of slow waves entrainment
Standard Deviation 2
|
|
Percentage of Slow Wave Entrainment
Post-Randomization Phase
|
84 percentage of slow waves entrainment
Standard Deviation 2
|
78 percentage of slow waves entrainment
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 WeeksThe retention of a study meal was measured at baseline, 1,2,3 and 4 hours of the test. The percent of food retained in a stomach at 4 hours was compared when MGP-1 was ON and OFF.
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
The Percent (Percentage) of Gastric Retention of a Solid Meal
Baseline Pre-Randomization Phase
|
46 percent of food retained
|
36 percent of food retained
|
|
The Percent (Percentage) of Gastric Retention of a Solid Meal
Post-Randomization Phase
|
33 percent of food retained
|
42 percent of food retained
|
SECONDARY outcome
Timeframe: 12 weeksMeasure represents change in symptom severity as measured by a self assessment Symptom Interview Form evaluating severity of vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain, and epigastric burning. Symptoms were rated from 0 - absence of symptom to 4 - extremely severe. The overall score was calculated from the sum of seven symptom sub-scores with a total possible score range of 0 - absence of all symptoms to 28 - all symptoms extremely severe.
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Severity of Gastroparetic Symptoms
Baseline Pre-Randomization Phase
|
13 units on a scale
Standard Deviation 1.2
|
14 units on a scale
Standard Deviation 1
|
|
Severity of Gastroparetic Symptoms
Post-Randomization Phase
|
6 units on a scale
Standard Deviation 1.1
|
16 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 12 WeeksMeasure represents percentage change from baseline to end of study. QoL measured using the Short Form Health Survey (SF-36) questionnaire. The SF-36 is a generic measure of QoL. Physical QoL (Physical Component Summary; PCS) and emotional QoL (Mental Component summary; MCS) scale components of the survey used for outcome. Scores range from 0 to 100 with lower scores indicating more disability and higher scores less disability.
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Physical Score
|
60 percentage change in scale score
Standard Deviation 21
|
30 percentage change in scale score
Standard Deviation 11
|
|
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Mental Score
|
55 percentage change in scale score
Standard Deviation 19
|
40 percentage change in scale score
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 12 WeeksHbA1c was evaluated at the baseline and after completion of all the phases of the study
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Changes in Hemoglobin A1c (HbA1c) Level
|
8.1 % HbA1c
Interval 7.6 to 10.3
|
8.2 % HbA1c
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: 12 WeeksMeasured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study.
Outcome measures
| Measure |
MGP-1 "ON"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "OFF"
n=8 Participants
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|
|
Changes in Hospital Admissions
|
1.5 days
Interval 0.0 to 4.0
|
2.1 days
Interval 0.0 to 7.0
|
Adverse Events
Open Label Run
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MGP-1 "ON"
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MPG-1 "OFF"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Run
n=22 participants at risk
Experimental Pacemaker on for 6 weeks during the open label phase (preceding MGP-1 "ON" and MPG-1 "OFF" randomization phases).
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MGP-1 "ON"
n=10 participants at risk
Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
MPG-1 "OFF"
n=9 participants at risk
Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
|---|---|---|---|
|
Gastrointestinal disorders
Dislodgement of the electrode(s)
|
0.00%
0/22 • Duration of the study, up to 12 weeks.
|
20.0%
2/10 • Number of events 2 • Duration of the study, up to 12 weeks.
|
0.00%
0/9 • Duration of the study, up to 12 weeks.
|
|
Product Issues
Technical issue with the MGP-1 system
|
4.5%
1/22 • Number of events 1 • Duration of the study, up to 12 weeks.
|
0.00%
0/10 • Duration of the study, up to 12 weeks.
|
0.00%
0/9 • Duration of the study, up to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place