Obesity
Conditions
Keywords
Obesity
Brief summary
The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.
Detailed description
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating whether the the GI Endobarrier Liner can be reimplanted.
Interventions
DEVICEEndobarrier Liner
Medical device placed endoscopically in the duodenum
Sponsors
Morphic Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years and \< 55 years - Male or Female * Previously implanted with the EndoBarrier Gastrointestinal Liner * Subjects willing to comply with trial requirements * Subjects who have signed an informed consent form * Women who are post-menopausal, surgically sterile or on oral contraceptives for the duration of the study and who do not plan on becoming pregnant during the course of the trial.
Exclusion criteria
* Treatment represents an unreasonable risk to the subject * Pregnant or have intention of becoming pregnant for the duration of the trial * Unresolved alcohol or drug addiction * Subjects receiving weight loss medications (prescription, over-the- counter, or herbal dietary medications) * Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Liner or the function of the implant. * Subjects with active and uncontrolled gastroesophageal reflux disease (GERD) * Subjects with symptomatic kidney stones prior to implant * Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan) * Subjects with iron deficiency and/or iron deficiency anemia * History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease * Subjects with symptomatic gallstones prior to implant * Symptomatic coronary artery disease or pulmonary dysfunction * Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn) * History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses * Pancreatitis or other serious organic conditions * Subjects requiring prescription anticoagulation therapy * Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period * Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder * Participating in another ongoing investigational clinical trial * Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial. * Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure) * Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the % Excess Weight Loss at Week 52 or Last Assessment | 52 Weeks | Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Absolute Weight Loss From Baseline to Week 52 | Week 52 |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoBarrier Liner Device All patients will be implanted with the Endobarrier Liner device
Endobarrier Liner: Medical device placed endoscopically in the duodenum | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Device migration | 1 |
Baseline characteristics
| Characteristic | EndoBarrier Liner Device |
|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 11.32 |
| Gender Female | 15 Participants |
| Gender Male | 4 Participants |
| Region of Enrollment Chile | 19 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 10 / 19 |
Outcome results
Primary
Assessment of the % Excess Weight Loss at Week 52 or Last Assessment
Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2
Time frame: 52 Weeks
Population: Full Analysis Set (FAS) population had a device successfully implanted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier Liner Device | Assessment of the % Excess Weight Loss at Week 52 or Last Assessment | 26.9 %EWL | Standard Deviation 20.35 |
Secondary
Change in Absolute Weight Loss From Baseline to Week 52
Time frame: Week 52
Population: Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier Liner Device | Change in Absolute Weight Loss From Baseline to Week 52 | -7.1 kg | Standard Deviation 3.34 |