Obesity
Conditions
Keywords
Weight Reduction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGI Sleeve Implantable weight loss device (EndoBarrier)
device for weight loss
PROCEDURESham Procedure
Weight loss
Sponsors
Morphic Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 35 with a significant comorbid condition or BMI 40-60 * Candidate for Bariatric Surgery
Exclusion criteria
* No pathologies of the GI Tract * No anti-coagulant or non-steroidal anti-inflammatory medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Excess Weight Loss (%EWL) at Week 12 | 3 months | Excess Weight Loss was calculated using the Metropolitan Life Table (MET method) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GI Sleeve medical device that mimics gastric bypass mechanism for weight-loss
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss | 21 |
| Sham Control Sham Procedure: Weight loss | 26 |
| Total | 47 |
Baseline characteristics
| Characteristic | GI Sleeve | Sham Control | Total |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 7.4 | 42.7 years STANDARD_DEVIATION 9.5 | 43.7 years STANDARD_DEVIATION 8.8 |
| Gender Female | 15 Participants | 23 Participants | 38 Participants |
| Gender Male | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment United States | 21 participants | 26 participants | 47 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 21 | 20 / 26 |
| serious Total, serious adverse events | 2 / 21 | 0 / 26 |
Outcome results
Primary
Percent Excess Weight Loss (%EWL) at Week 12
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GI Sleeve | Percent Excess Weight Loss (%EWL) at Week 12 | 11.9 Percentage of Excess Weight Loss | Standard Deviation 1.4 |
| Sham Control | Percent Excess Weight Loss (%EWL) at Week 12 | 2.7 Percentage of Excess Weight Loss | Standard Deviation 2 |