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Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01372501
First received: June 10, 2011
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.


Condition Intervention Phase
Obesity
Device: Endobarrier Liner
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Assessment of the % excess weight loss [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in absolute weight loss and percent (%) body weight loss [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Device
All patients will be implanted with the Endobarrier Liner device
Device: Endobarrier Liner
Medical device placed endoscopically in the duodenum
Other Name: GI Sleeve

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years and < 55 years - Male or Female
  • Previously implanted with the EndoBarrier Gastrointestinal Liner
  • Subjects willing to comply with trial requirements
  • Subjects who have signed an informed consent form
  • Women who are post-menopausal, surgically sterile or on oral contraceptives for the duration of the study and who do not plan on becoming pregnant during the course of the trial.

Exclusion Criteria:

  • Treatment represents an unreasonable risk to the subject
  • Pregnant or have intention of becoming pregnant for the duration of the trial
  • Unresolved alcohol or drug addiction
  • Subjects receiving weight loss medications (prescription, over-the- counter, or herbal dietary medications)
  • Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Liner or the function of the implant.
  • Subjects with active and uncontrolled GERD
  • Subjects with symptomatic kidney stones prior to implant
  • Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
  • Subjects with iron deficiency and/or iron deficiency anemia
  • History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
  • Subjects with symptomatic gallstones prior to implant
  • Symptomatic coronary artery disease or pulmonary dysfunction
  • Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
  • History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
  • Pancreatitis or other serious organic conditions
  • Subjects requiring prescription anticoagulation therapy
  • Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Participating in another ongoing investigational clinical trial
  • Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial.
  • Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
  • Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372501

Locations
Chile
Dr. Alex P Escalona
Santiago, Chile
Sponsors and Collaborators
GI Dynamics
Investigators
Principal Investigator: Alex P Escalona, MD Pontificia Universidad Catolica de Chile, Santiago, Chile
  More Information

No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01372501     History of Changes
Other Study ID Numbers: 09-3
Study First Received: June 10, 2011
Last Updated: May 10, 2013
Health Authority: Chile: Comision Nacional de Investigacion Cientifica y Tenologica

Keywords provided by GI Dynamics:
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014