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 the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GI Sleeve | Experimental | medical device that mimics gastric bypass mechanism for weight-loss |
|
| Sham Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Sleeve Implantable weight loss device (EndoBarrier) | Device | device for weight loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Excess Weight Loss (%EWL) at Week 12 | Excess Weight Loss was calculated using the Metropolitan Life Table (MET method) | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Tarnoff, MD | Tufts Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| Lahey Clinic Medical Center |
De-identified individual patient data is on file at the Sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GI Sleeve | GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy |
| FG001 | Sham Control | Sham Procedure followed by standard-of-care diet therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT population: All subjects who did not withdraw before the procedure and device subjects who had a successful implant procedure
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GI Sleeve | medical device that mimics gastric bypass mechanism for weight-loss GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss |
| BG001 | Sham Control |
| 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 | Percent Excess Weight Loss (%EWL) at Week 12 | Excess Weight Loss was calculated using the Metropolitan Life Table (MET method) | Posted | Mean | Standard Deviation | Percentage of Excess Weight Loss | 3 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 | GI Sleeve | N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | GI Dynamics, Inc. | 781.357.3261 | pkeating@gidynamics.com |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Procedure | Procedure | Weight loss |
|
|
| Burlington |
| Massachusetts |
| 01805 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232 | United States |
Sham Procedure: Weight loss
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 2 |
| 21 |
| 21 |
| 21 |
| EG001 | Sham Control | 3 subjects withdrew before the procedure. N=26 for the ITT population. | 0 | 26 | 20 | 26 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Adverse drug reaction | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Gastrointestinal disorders | 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 |
|
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |