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Trial record 11 of 20 for:    GI Dynamics

EndoBarrier System Pivotal Trial(Rev B) (STEP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101669
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Biostatistical Consulting, Inc.
Information provided by (Responsible Party):
GI Dynamics

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE September 9, 2019
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Change in HbA1c [ Time Frame: One year ]
Change in HbA1c value from baseline to 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • HbA1c value [ Time Frame: 1 and 2 years ]
    Proportion of patients who achieve an HbA1c value of < 7 % by 12 months (52 weeks).
  • Weight Loss [ Time Frame: 1 and 2 years ]
    Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
  • Insulin use [ Time Frame: 1 and 2 years ]
    Proportion of patients initiating insulin
  • LDL cholesterol [ Time Frame: 1 and 2 years ]
    Change in LDL cholesterol
  • Triglycerides [ Time Frame: 1 and 2 years ]
    Change in triglycerides
  • Blood pressure [ Time Frame: 1 and 2 years ]
    Change in systolic blood pressure values
  • Change in daily fasting glucose level [ Time Frame: 1 and 2 years ]
    Change in fasting blood glucose values as measured by daily glucometer reading in mg/dL
  • Change in Nonalcoholic Fatty Liver Disease (NAFLD) [ Time Frame: 1 and 2 years ]
    Change in NAFLD, change in % liver fat using MRI (proton density fat fraction)
  • Change in Nonalcoholic Steatohepatitis (NASH) [ Time Frame: 1 and 2 years ]
    NASH- liver fibrosis % compared to baseline using using MRE measured in kPa
  • HOMA-IR [ Time Frame: 1 and 2 years ]
    Change in HOMA-IR (using fasting glucose and fasting insulin)
  • Questionnaire [ Time Frame: 1 and 2 years ]
    Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ)
  • Change in Risk Level of CKD eGFR [ Time Frame: 1 and 2 years ]
    Change in eGFR
  • Change in Risk Level of CKD albumin [ Time Frame: 1 and 2 years ]
    Change in albumin level
  • Questionnaire [ Time Frame: 1 and 2 years ]
    Change in impact of weight on life from baseline using Weight on Quality of Life (IWQOL-lite)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EndoBarrier System Pivotal Trial(Rev B)
Official Title  ICMJE A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier® System for Glycemic Improvement in Patients With Inadequately Controlled Type 2 Diabetes and Obesity
Brief Summary

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study.

A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (EndoBarrier):1 (Sham).

Detailed Description

The objective of this study is to evaluate the safety and effectiveness of the EndoBarrier System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 8.0% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least triple therapy for 3 months, excluding insulin, yet have not achieved adequate HbA1c control (<7%).

Specific objectives of this study are:

  1. To determine if the EndoBarrier System significantly improves glycemic control
  2. To determine that the EndoBarrier System can be safely used to improve glycemic control
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System. Patients will be randomized 3 (EndoBarrier):1 (Sham).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The Investigators include interventional gastroenterologists (GI) and endocrinologists. The GI team: MD, PA and site coordinator, as well as radiology personnel will not be masked, while the endocrinologist team: the MDs, PAs, site coordinators and nutritionists, will be masked. The patient is also masked.
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes type2
  • Obesity
Intervention  ICMJE
  • Device: EndoBarrier Liner
    The EndoBarrier System is provided as a single-use, sterile device and consists of an EndoBarrier Liner preloaded, packaged and sterilized within the EndoBarrier Delivery System. The EndoBarrier Delivery System is utilized to deliver the EndoBarrier Liner to the proximal small intestine. The EndoBarrier Liner is removed using the EndoBarrier Retrieval System. The EndoBarrier System incorporates no pharmacological, biological tissue or blood products.
    Other Names:
    • EndoBarrier Sleeve
    • Duodenal-jejunal Bypass Liner (DJBL)
  • Other: Sham
    Patient receives upper endoscopy but no treatment
Study Arms  ICMJE
  • Experimental: EndoBarrier
    Patients in ARM 1, will receive an upper endoscopy and will be treated with the EndoBarrier Liner
    Intervention: Device: EndoBarrier Liner
  • Sham Comparator: Sham
    Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the EndoBarrier Liner.
    Intervention: Other: Sham
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2024
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥30 years and ≤ 55 years
  2. Have understood and signed the approved informed consent form
  3. Diagnosis of type 2 diabetes for ≤ 15 years
  4. HbA1c ≥ 8.0% and ≤10%
  5. BMI ≥30kg/m2 and ≤ 50kg/m2
  6. Willing and able to comply with study requirements
  7. Documented negative pregnancy test in women of childbearing potential
  8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 2 forms of birth-control to prevent unwanted pregnancies
  9. At least one year of medical records available, including detailed medical therapy and dosing information
  10. Failed to achieve adequate HbA1c reduction (<7%) after triple therapy for at least 3-month stable dosage of diabetes medication(s), including metformin, SGLT-2 inhibitor, GLP-1 RA or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s. Use of insulin is an exclusion criterion. Patients should be at 70% of maximum dosage of diabetes medications or highest tolerable dosage.

Exclusion Criteria:

  1. Previous treatment with the EndoBarrier System
  2. Previous GI surgery that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner, or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner
  3. Known history of liver disease (e.g., viral, autoimmune, fibrosis/cirrhosis etiology, but not including incidental fatty liver)
  4. eGFR of less than 45 ml/min/1.73 m2
  5. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
  6. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
  7. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  8. Fasting C-peptide < 1.0 ng/mL
  9. Triglyceride level > 600 mg/dL
  10. Vitamin D deficiency (<30ng/ml)
  11. Male patients with serum creatinine (Cr) >1.5 mg/dl or female patients with Cr >1.4 mg/dl
  12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  13. Height < 5 feet (152.4 cm)
  14. Current or past alcohol addiction, current or past drug addiction, or current drug usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
  15. History of pancreatitis
  16. Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
  17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
  18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) and utilizing PPI to treat.
  19. Thyroid disease
  20. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post implant procedure
  21. Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:

    Restricted Medications/Supplements Systemic corticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide) Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)

    Supplements that are known or suspected to increase bleeding risk including but not limited to:

    Gingko biloba Ginseng Vitamins C & E Turmeric St. John's wort Evening primrose oil Feverfew Green Tea Extract

  22. Allergy or hypersensitivity to cephalosporins or penicillin and all equivalent antibiotics
  23. Active H. pylori
  24. History of Crohn's disease, atresias or untreated stenoses
  25. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
  26. Any condition or major illness that places the patient at undue risk by participating in the study, including but not limited to, patients at significant risk for surgery because of potential need for surgery to address adverse events
  27. Poor dentition not allowing complete chewing of food
  28. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
  29. Residing in a location without ready access to study site medical resources
  30. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
  31. Positive Fecal Immunochemical Test (FIT) at time of screening
  32. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
  33. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
  34. Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study
  35. Any condition that increases red cell turnover, such as thalassemia
  36. Existence of Pseudomonas, Stenotrophomonas, and/or Klebsiella as measured in oral or rectal swab
  37. A known sensitivity to nickel or titanium
  38. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)
  39. Current use of insulin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen J Linhares, BS 774-454-3259 slinhares@gidynamics.com
Contact: Scott Schorer, BA 774-454-7407 sschorer@gidynamics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04101669
Other Study ID Numbers  ICMJE 18-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GI Dynamics
Study Sponsor  ICMJE GI Dynamics
Collaborators  ICMJE Biostatistical Consulting, Inc.
Investigators  ICMJE
Principal Investigator: Christopher C Thompson, MD Brigham and Women's Hospital
PRS Account GI Dynamics
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP