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This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic.
A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes.
If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterra Therapy | Device | Gastric electrical stimulation using Enterra Therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF | Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON. | 4.5 months and 7.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF | A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders at 12 Months | Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%. | baseline and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darin R Lerew, PhD | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Medtronic for exact location | San Francisco | California | United States | |||
| Contact Medtronic for exact location |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20538073 | Derived | McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010 Nov;8(11):947-54; quiz e116. doi: 10.1016/j.cgh.2010.05.020. Epub 2010 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic: ON First, Then OFF | This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months. |
| FG001 | Diabetic: OFF First, Then ON | This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months. |
| FG002 | Diabetic: Not Randomized | This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months. |
| FG003 | Idiopathic: ON First, Then OFF | This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months. |
| FG004 | Idiopathic: OFF First, Then ON | This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months. |
| FG005 | Idiopathic: Not Randomized | This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic | This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort. |
| BG001 | Idiopathic | This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort. |
| 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 | Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF | Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON. | The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements. | Posted | Median | Full Range | percent reduction in WVF | 4.5 months and 7.5 months |
|
Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study.
All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
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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 | Diabetic | This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) |
Early termination of the study impacted the ability to analyze the primary endpoint and secondary endpoint 1 for the idiopathic arm of the study. The minimum sample size for analysis of these endpoints was 32 subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Medtronic Neuromodulation | 763-526-8172 | medtronicneurotrials@medtronic.com |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 4.5 months and 7.5 months |
| Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline | Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months. | baseline and 12 months |
| Change in Symptom Score at 12 Months Compared to Baseline. | A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months. | baseline and 12 months |
| Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary) | The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL. | baseline and 12 months |
| Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary) | The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL. | baseline and 12 months |
| Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours) | Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months. | baseline and 12 months |
| Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours) | Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months. | baseline and 12 months |
| Washington D.C. |
| District of Columbia |
| United States |
| Contact Medtronic for exact location | Anderson | Indiana | United States |
| Contact Medtronic for exact location | Kansas City | Kansas | United States |
| Contact Medtronic for exact location | Louisville | Kentucky | United States |
| Contact Medtronic for exact location | Philadelphia | Pennsylvania | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Explant due to infection |
|
| Medical reason |
|
| Study site closure |
|
| Subject non-compliance |
|
| Study completion |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Idiopathic | This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort. |
|
|
|
| Secondary | Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF | A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON. | The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements. | Posted | Median | Full Range | Percent reduction in symptom score | 4.5 months and 7.5 months |
|
|
|
|
| Secondary | Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline | Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months. | The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements. | Posted | Median | Full Range | Percent reduction in WVF | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Percentage of Responders at 12 Months | Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%. | The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements. | Posted | Number | Percentage of responders | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Change in Symptom Score at 12 Months Compared to Baseline. | A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months. | The analysis population included subjects who were randomized and completed the study at 12 months. | Posted | Mean | Standard Deviation | Scores on a scale | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary) | The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL. | The analysis population included subjects who were randomized and completed the study at 12 months. | Posted | Mean | Standard Deviation | Scores on a scale | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary) | The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL. | The analysis population included subjects who were randomized and completed the study at 12 months. | Posted | Mean | Standard Deviation | Scores on a scale | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours) | Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months. | The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements. | Posted | Median | Inter-Quartile Range | Percent retention | baseline and 12 months |
|
|
|
|
| Other Pre-specified | Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours) | Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months. | The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements. | Posted | Median | Inter-Quartile Range | Percent retention | baseline and 12 months |
|
|
|
|
| 8 |
| 55 |
| 13 |
| 55 |
| EG001 | Idiopathic | This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort. | 4 | 32 | 9 | 32 |
| Central venous catheterisation | Surgical and medical procedures | MedDRA (8.0) |
|
| Chest pain | General disorders | MedDRA (8.0) |
|
| Death | General disorders | MedDRA (8.0) |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (8.0) |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (8.0) |
|
| High lead impedance | General disorders | MedDRA (8.0) |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (8.0) |
|
| Implant site haematoma | General disorders | MedDRA (8.0) |
|
| Implant site infection | Infections and infestations | MedDRA (8.0) |
|
| Lead migration/dislodgment | General disorders | MedDRA (8.0) |
|
| Migration of implant | General disorders | MedDRA (8.0) |
|
| Neurostimulator migration | General disorders | MedDRA (8.0) |
|
| Paraesthesia | Nervous system disorders | MedDRA (8.0) |
|
| Pneumonia | Infections and infestations | MedDRA (8.0) |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (8.0) |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (8.0) |
|
| Lead impedance NOS or high lead impedance | General disorders | MedDRA (8.0) |
|
| Paraesthesia | Nervous system disorders | MedDRA (8.0) |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
|
Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0; Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0 |
| Wilcoxon Signed Rank Test |
| 0.932 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0; Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0 |
| Wilcoxon Signed Rank Test |
| <0.001 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: The percentage of responders was less than or equal to 50%; Alternative hypothesis: The percentage of responders was greater than 50% |
| binomial, 1 sided |
| <0.001 |
A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons. |
| No |
| Superiority or Other |
Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0; Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0 |
| Paired t-test |
| <0.001 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0; Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0 |
| Paired t-test |
| 0.043 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0; Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0 |
| Paired t-test |
| 0.001 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0; Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0 |
| Wilcoxon Signed Rank Test |
| <0.001 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0; Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0 |
| Wilcoxon Signed Rank Test |
| 0.236 |
A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |