EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

GI Dynamics

Status

Terminated

Conditions

Obesity

Type 2 Diabetes

Treatments

Device: EndoBarrier SANS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02443753

15-1

Details and patient eligibility

About

This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.

Full description

The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.

This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.

Enrollment

7 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 21 years and < 65 years - male or female
Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
Glycemic state: HbA1c at screening 7.0-10.0%.
History of failure with non-surgical weight loss methods
Subjects willing to comply with study requirements
Subjects who have signed an informed consent form

Exclusion criteria

Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)

Subjects requiring anticoagulation therapy
Subjects with iron deficiency and iron deficiency anemia
Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
Treatment represents an unreasonable risk to the subject
Known history of acute or chronic pancreatitis
Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
Symptomatic coronary artery disease or pulmonary dysfunction
Subjects with known symptomatic biliary disease
Known infection at the time of implant
Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Congenital or acquired anomalies of the GI tract such as atresias or stenoses
Pregnant or has the intention of becoming pregnant in the next 6 months
Unresolved alcohol or drug addiction
HIV positive subjects
Subjects with hepatitis B or C
Currently taking the following medications within 30 days of implant:

systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat

Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
Previous GI surgery that could affect the ability to place the liner or the function of the implant.
Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Unable to tolerate proton pump inhibitors
Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
Positive stool guaiac at time of screening