- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443753
EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kuala Lumpur, Malaysia, 50603
- Universiti Malaya Medical Centre, Jalan universiti
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device
Subjects who receive the device
|
Eligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
Time Frame: 3 months
|
Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy as measured by Change in Body weight
Time Frame: 3 months
|
Change in Body weight
|
3 months
|
Efficacy as measured by Percent excess weight loss
Time Frame: 3 months
|
Percent excess weight loss
|
3 months
|
Efficacy as measured by Change in HbA1c (%)
Time Frame: 3 months
|
Change in HbA1c (%)
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eng Hong Pok, MD, University of Malaya
- Principal Investigator: Wah Kheong Chan, MD, University of Malaya
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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