Gastric Stasis
Conditions
Brief summary
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
Detailed description
Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.
Interventions
DEVICEEnterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)
Sponsors
GI Stimulation, Inc.
National Institutes of Health (NIH)
American Diabetes Association
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Severe nausea and vomiting for at least 6 months * Documented delayed gastric emptying * Failed extensive medical treatment
Exclusion criteria
* Previous gastric surgery * Pregnancy or planned pregnancy * Primary eating or swallowing disorders * Scheduled or planned MRI testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Slow Wave Entrainment | 12 Weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percent (Percentage) of Gastric Retention of a Solid Meal | 12 Weeks | The 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. |
| Severity of Gastroparetic Symptoms | 12 weeks | Measure 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. |
| Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | 12 Weeks | Measure 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. |
| Changes in Hemoglobin A1c (HbA1c) Level | 12 Weeks | HbA1c was evaluated at the baseline and after completion of all the phases of the study |
| Changes in Hospital Admissions | 12 Weeks | Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 10 |
| 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) | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | MGP-1 OFF | MGP-1 ON | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 40 years | 42 years | 42 years |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 1 / 22 | 2 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 22 | 0 / 10 | 0 / 9 |
Outcome results
Primary
Percentage of Slow Wave Entrainment
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
Time frame: 12 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MGP-1 ON | Percentage of Slow Wave Entrainment | Baseline Pre-Randomization Phase | 72 percentage of slow waves entrainment | Standard Deviation 3 |
| MGP-1 ON | Percentage of Slow Wave Entrainment | Post-Randomization Phase | 84 percentage of slow waves entrainment | Standard Deviation 2 |
| MGP-1 OFF | Percentage of Slow Wave Entrainment | Baseline Pre-Randomization Phase | 70 percentage of slow waves entrainment | Standard Deviation 2 |
| MGP-1 OFF | Percentage of Slow Wave Entrainment | Post-Randomization Phase | 78 percentage of slow waves entrainment | Standard Deviation 1.5 |
Secondary
Changes in Hemoglobin A1c (HbA1c) Level
HbA1c was evaluated at the baseline and after completion of all the phases of the study
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MGP-1 ON | Changes in Hemoglobin A1c (HbA1c) Level | 8.1 % HbA1c |
| MGP-1 OFF | Changes in Hemoglobin A1c (HbA1c) Level | 8.2 % HbA1c |
Secondary
Changes in Hospital Admissions
Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study.
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MGP-1 ON | Changes in Hospital Admissions | 1.5 days |
| MGP-1 OFF | Changes in Hospital Admissions | 2.1 days |
Secondary
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Measure 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.
Time frame: 12 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MGP-1 ON | Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | Physical Score | 60 percentage change in scale score | Standard Deviation 21 |
| MGP-1 ON | Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | Mental Score | 55 percentage change in scale score | Standard Deviation 19 |
| MGP-1 OFF | Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | Physical Score | 30 percentage change in scale score | Standard Deviation 11 |
| MGP-1 OFF | Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | Mental Score | 40 percentage change in scale score | Standard Deviation 14 |
Secondary
Severity of Gastroparetic Symptoms
Measure 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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MGP-1 ON | Severity of Gastroparetic Symptoms | Baseline Pre-Randomization Phase | 13 units on a scale | Standard Deviation 1.2 |
| MGP-1 ON | Severity of Gastroparetic Symptoms | Post-Randomization Phase | 6 units on a scale | Standard Deviation 1.1 |
| MGP-1 OFF | Severity of Gastroparetic Symptoms | Baseline Pre-Randomization Phase | 14 units on a scale | Standard Deviation 1 |
| MGP-1 OFF | Severity of Gastroparetic Symptoms | Post-Randomization Phase | 16 units on a scale | Standard Deviation 1.1 |
Secondary
The Percent (Percentage) of Gastric Retention of a Solid Meal
The 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.
Time frame: 12 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MGP-1 ON | The Percent (Percentage) of Gastric Retention of a Solid Meal | Baseline Pre-Randomization Phase | 46 percent of food retained |
| MGP-1 ON | The Percent (Percentage) of Gastric Retention of a Solid Meal | Post-Randomization Phase | 33 percent of food retained |
| MGP-1 OFF | The Percent (Percentage) of Gastric Retention of a Solid Meal | Post-Randomization Phase | 42 percent of food retained |
| MGP-1 OFF | The Percent (Percentage) of Gastric Retention of a Solid Meal | Baseline Pre-Randomization Phase | 36 percent of food retained |