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

NCT03072901 | Terminated FDA Device

• 1 other identifier: 10-3
• Study Type: observational
• Target: 244
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events

  24 months

• Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control

  Change in %HbA1c from Baseline

  Change from Baseline measured up to 24 months

• Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss

  Change from Baseline of weight (kg)

  Change from Baseline measured up to 24 months

Study Arms (1)

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.

Device: EndoBarrier Gastrointestinal Liner

Interventions

EndoBarrier Gastrointestinal Liner DEVICE

The EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months.

EndoBarrier Gastrointestinal Liner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Morphic Medical Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith Gersin, MD

  GI Dynamics, Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: March 7, 2017
• Study Start: December 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share