Clinical trial NCT03072901: Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
Official title: Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry was open to subjects who met the EndoBarrier's Indications for Use, inclusion/exclusion criteria and contraindications in the device's Instructions For Use at the time the Registry was initiated.

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.

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/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)

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 24 months
measure: Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control
timeFrame: Change from Baseline measured up to 24 months
measure: Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss
timeFrame: Change from Baseline measured up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GI Dynamics, Medical Director
name: Keith Gersin, MD
role: STUDY_DIRECTOR
References: