NCT00985491

Brief Summary

The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2016

Completed
Last Updated

September 15, 2016

Status Verified

February 1, 2016

Enrollment Period

6.8 years

First QC Date

September 25, 2009

Results QC Date

February 13, 2016

Last Update Submit

August 3, 2016

Conditions

Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

  • Assessment of % Excess Weight Loss

    Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).

    12 months

Secondary Outcomes (1)

  • Improvement in Type 2 Diabetic Status

    12 months

Study Arms (1)

Device

EXPERIMENTAL

All patients will be implanted with the Endobarrier Liner device.

Device: Endobarrier Liner

Interventions

Endobarrier LinerDEVICE

Medical device placed endoscopically in the duodenum

Also known as: GI Sleeve
Device

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 years and \< 55 years - Male or Female
  • BMI \> 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or \> 40 BMI \<60 (with or without a co-morbid condition)
  • History of failure with nonsurgical weight loss methods
  • Candidates for Roux-en-Y gastric bypass
  • Willing to comply with trial requirements
  • Signed an ICF
  • Post-menopausal women with surgical sterilization or following any treatment or family planning and not planning to become pregnant during the course of the investigation

You may not qualify if:

  • 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
  • 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
  • Active GERD
  • Symptomatic kidney stones prior to implant
  • 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
  • Symptomatic gallstones prior to implant
  • Symptomatic coronary artery disease or pulmonary dysfunction
  • Known infection at the time of implant
  • History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
  • Pancreatitis or other serious organic conditions
  • Requiring prescription anticoagulation therapy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Nicholas Quezada

Santiago, Chile

Location

Related Publications (1)

  • Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4.

    PMID: 22534421DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Manager of Clinical Affairs
Organization
GI Dynamics, Inc.
pkeating@gidynamics.com
781.357.3261

Study Officials

  • Alex P Escalona, MD

    Pontificia Universidad Catolica de Chile, Santiago, Chile

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 15, 2016

Results First Posted

August 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

CL(1)