Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Morphic Medical Inc.
- Enrollment
- 244
- Primary Endpoint
- Incidence of Adverse Events
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
Detailed Description
This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.
Investigators
Eligibility Criteria
Inclusion Criteria
- •As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m
- •The GI liner is indicated for a maximum implant duration of 12 months.
Exclusion Criteria
- •As per Instructions For Use (IFU)
- •Women who are pregnant
- •Requirement for prescription anticoagulation therapy
- •History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease
- •Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •History of coagulopathy
- •Bleeding diathesis, upper GI bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia
- •Congenital or acquired anomalies of the GI tract such as atresias or stenosis
- •Previous GI surgery that could affect the ability to place the EndoBarrier Gastrointestinal Liner or its function
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: 24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control
Time Frame: Change from Baseline measured up to 24 months
Change in %HbA1c from Baseline
Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss
Time Frame: Change from Baseline measured up to 24 months
Change from Baseline of weight (kg)