Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoBarrier GI Liner | Experimental | 22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Liner | Device | Medical device placed endoscopically in the duodenum, nutritional counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of Excess Weight Loss (EWL) | Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Values at 12 Months | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eduardo Guimaraes Hourneaux de Moura, MD | Hospital das Clinicas, Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Eduardo Guimaraes Hourneauz de Moura | São Paulo | São Paulo | 05493900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21932999 | Result | de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EndoBarrier | Subjects implanted with the EndoBarrier for up to 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EndoBarrier Liner Device | Subjects implanted with the EndoBarrier for up to 12 months. |
| 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 | % of Excess Weight Loss (EWL) | Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100 | Posted | Mean | Standard Deviation | % excess weight loss | 12 months |
|
|
Not provided
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 | EndoBarrier | Subjects implanted with the EndoBarrier for up to 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager, Clinical and Regulatory | GI Dynamics, Inc. | 781.357.3263 | kwoessner@gidynamics.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| abdominal tumor, unrelated to device |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Weight | Mean | Standard Deviation | kg |
|
| Percent of glycosylated hemoglobin | Mean | Standard Deviation | Percent of glycosylated hemoglobin |
|
|
| Secondary | HbA1c Values at 12 Months | Posted | Mean | Standard Deviation | HbA1c (%) | 12 months |
|
|
|
| 2 |
| 22 |
| 22 |
| 22 |
| Abdominal neoplasm | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supra-ventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastric hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Panic reaction | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |