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| Name | Class |
|---|---|
| GI Stimulation, Inc. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| American Diabetes Association | OTHER |
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Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGP-1 ON | Active Comparator | Experimental Pacemaker on for 6 weeks |
|
| MGP-1 OFF | Active Comparator | Experimental Pacemaker on or off for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) | Device | Multi-Channel Phased Gastric Pacemaker (MGP-1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Severity of Gastroparetic Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W. McCallum, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Run in |
|
| |||||||||||||||||||||
| Randomization and Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | MGP-1 "OFF" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | percentage of slow waves entrainment | 12 Weeks |
|
Duration of the study, up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Run | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislodgement of the electrode(s) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Sarosiek, MD, AGAF, FACG, CCRP | Texas Tech | 915.215.5254 | Irene.sarosiek@ttuhsc.edu |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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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. |
| 12 weeks |
| 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. | 12 Weeks |
| Changes in Hemoglobin A1c (HbA1c) Level | HbA1c was evaluated at the baseline and after completion of all the phases of the study | 12 Weeks |
| 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. | 12 Weeks |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Number | percent of food retained | 12 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change in scale score | 12 Weeks |
|
|
|
| Secondary | Changes in Hemoglobin A1c (HbA1c) Level | HbA1c was evaluated at the baseline and after completion of all the phases of the study | Posted | Mean | Full Range | % HbA1c | 12 Weeks |
|
|
|
| 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. | Posted | Mean | Full Range | days | 12 Weeks |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | 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) | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | MPG-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) | 0 | 9 | 0 | 9 | 0 | 9 |
| Technical issue with the MGP-1 system | Product Issues | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |