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| ID | Type | Description | Link |
|---|---|---|---|
| 900000 |
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Failure to achieve one of the primary endpoints.
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| Name | Class |
|---|---|
| MED Institute, Incorporated | INDUSTRY |
| Cook Endoscopy | INDUSTRY |
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The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.
Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | palliative treatment of gastric outlet obstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Magnetic Anastomosis Device (MAD) with Stent | Device | Gastro-jejunal anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent | Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent. | Approximately 8-10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Fockens, MD, PhD | Amsterdam Academic Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Erasme | Brussels | Belgium | ||||
| Instituto di Clinical Chirurgica |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Anastomosis Device (MAD) With Stent | Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Anastomosis Device (MAD) With Stent | Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent | Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent. | Posted | Number | participants | Approximately 8-10 days |
|
|
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Only 12 of 18 patients are reported in the reported Adverse Events section as "Total Number of Participants at Risk". These are the participants that received both the magnets and the stent (primary success).
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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 | Magnetic Anastomosis Device (MAD) With Stent | Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Blood and lymphatic system disorders | Death was due to peritonitis/sepsis subsequent to stent migration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migration | Gastrointestinal disorders |
Enrollment was stopped in Feb 2009, due to the death of a patient after distal stent migration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, Ph.D., Manager, Biostatistics and Data Management, Senior Statistician | MED Institute, Inc. | 765-463-7537 | ssnyder@medinst.com |
| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
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| Rome |
| Italy |
| Amsterdam Academic Medical Center | Amsterdam | Netherlands |
| University Medical Center Utrecht | Utrecht | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Karnofsky Score | The Karnofsky score allows patients to be classified as to their functional impairment. It runs from 100 to 0, where 100 is "perfect" health and 0 is death. | Mean | Standard Deviation | Units on a scale |
|
| Presenting Condition | Number | participants |
|
| Current Treatments | Number | participants |
|
|
|
| Post-Hoc | Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD) | Endoscopy was performed to determine whether an anastomosis (hole) was successfully created. | Patients who underwent a second endoscopy after successful magnet placement | Posted | Number | participants | Approximately 8-10 days |
|
|
|
| 10 |
| 12 |
| 4 |
| 12 |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Deaths were due to progressive malignancy. |
|
| Death | Cardiac disorders | Death was due to co-morbidity. |
|
Each PI/site is restricted from making any publication until the multi-center publication has been presented (published) or 12 months after conclusion/abandonment/or termination of the Study (in the case where the multi-center publication has not been submitted within the 12 months) or Cook confirms there will be no multi-center publication.
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |