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Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372501
First Posted: June 14, 2011
Last Update Posted: February 15, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
GI Dynamics
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Assessment of the % Excess Weight Loss at Week 52 or Last Assessment [ Time Frame: 52 Weeks ]
    Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2


Secondary Outcome Measures:
  • Change in Absolute Weight Loss From Baseline to Week 52 [ Time Frame: Week 52 ]

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

Detailed Description:
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating whether the the GI Endobarrier Liner can be reimplanted.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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 gastroesophageal reflux disease (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01372501     History of Changes
Other Study ID Numbers: 09-3
First Submitted: June 10, 2011
First Posted: June 14, 2011
Results First Submitted: February 13, 2016
Results First Posted: March 11, 2016
Last Update Posted: February 15, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual data is available on site at Sponsor

Keywords provided by GI Dynamics:
Obesity