Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

Terminated

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Device: EndoBarrier Gastrointestinal Liner

• Registration Number: NCT03072901
• Lead Sponsor: Morphic Medical Inc.

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Study First Submitted: 2017-01-19
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-07
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 244

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/m2. 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
• Iron deficiency and/or iron deficiency anemia
• Active symptoms of kidney stones or known presence of gallstones
• Inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period
• Family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
• H. pylori positive status (Patients may receive the EndoBarrier Gastrointestinal Liner if they had a prior history and were successfully treated)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EndoBarrier Gastrointestinal Liner	EndoBarrier Gastrointestinal Liner	244 subjects; The registry will be open to subjects who meet the EndoBarrier's Indications for Use and none of the Contraindications in the device's Instructions For Use document. Subjects who successfully receive the device implant at a participating registry center will be included in the registry.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control	Change from Baseline measured up to 24 months	Change in %HbA1c from Baseline
Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss	Change from Baseline measured up to 24 months	Change from Baseline of weight (kg)