Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.
Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Stimulation Days1-4/Sham5-8 | Active Comparator | The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days |
|
| Sham1-4/Gastric Stimulation Days5-8 | Active Comparator | The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Electrical Stimulator, Enterra, Medtronics, Inc. | Device | All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom of Vomiting Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Study Day 0 (Baseline), Day 3, Day 7 |
| Symptom of Nausea Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Study Day 0 (Baseline), Day 3, Day 7 |
| Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day. | Study Day 0 (Baseline), Day 4, Day 8 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas L Abell, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21872708 | Result | Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022. |
| Label | URL |
|---|---|
| Pub Med abstract of study as reported in "Gastrointestinal Endoscopy" | View source |
Not provided
No significant events or approaches for the overall study following participant enrollment were performed prior to group assignment.
Patients seeking temporary gastric electric stimulator devices for drug-refractory gastroparesis between August 2005 and October 2006 who met the inclusion criteria and did not have any of the exclusion criteria were offered access to the research protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Stimactivated Days1-4/Not Activated Days5-8 | The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days |
| FG001 | Gastric StimulationNotActivated Days1-4/Activated Days5-8 | The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Stimactivated Days1-4/Not Activated Days5-8 | The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days |
| 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 | Symptom of Vomiting Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Posted | Dec 2010 | Mean | Standard Error | Patient Self-reported Symptom Score | Study Day 0 (Baseline), Day 3, Day 7 |
|
Study Days 0-8 (Entirety of Study)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gastric Stimactivated | Gastric Electrical Stimulation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Dislodgment | Gastrointestinal disorders | Lead Dislodgment | Systematic Assessment | All lead dislodgment occurred by Day 4. |
New lead implantation techniques now minimize dislodgment (only adverse effect); Parallel, non-crossover protocol will address any carry-over effect after tGES activation OFF; stratification for baseline mucosal EGG and medications may be useful.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas L. Abell, MD, Professor of Medicine | University of Mississippi Medical Center | 6019844540 | tabell@umc.edu |
Not provided
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| BG001 | Gastric StimulationNotActivated Days1-4/Activated Days5-8 | The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours. |
| 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 |
|
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|
| Primary | Symptom of Nausea Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Posted | Dec 2010 | Mean | Standard Error | Patient Self-reported Symptom Score | Study Day 0 (Baseline), Day 3, Day 7 |
|
|
|
| Primary | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day. | Posted | Dec 2010 | Mean | Standard Error | percentage of radiolabeled meal in stoma | Study Day 0 (Baseline), Day 4, Day 8 |
|
|
|
| 0 |
| 51 |
| 6 |
| 51 |
| EG001 | Gastric StimulationNotActivated | Sham stimulation | 0 | 52 | 7 | 52 |
|
Not provided
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Nausea Score Day 7 |
|
| GET Day 0, at 4th hour |
|
| GET Day 4, at 1st hour |
|
| GET Day 4, at 2nd hour |
|
| GET Day 4, at 4th hour |
|
| GET Day 8, at 1st hour |
|
| GET Day 8, at 2nd hour |
|
| GET Day 8, at 4th hour |
|