ObesityPhase 2NCT00985491
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
A Phase 2 study testing Endobarrier Liner in people with Obesity, run by Morphic Medical Inc. at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endobarrier Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChile
- Study dates
- Oct 2008to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- Having 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
- Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
- Having or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
Read the 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 the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.
- Conditions
- Obesity
- Being tested
- Endobarrier Liner
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobarrier LinerDevice
Also called GI Sleeve
Medical device placed endoscopically in the duodenum
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | All patients will be implanted with the Endobarrier Liner device. Receives: Device: Endobarrier Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
Improvement in Type 2 Diabetic Status
Subjects who achieved HbA1c reduction of 0.5%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex P Escalona, MD, Principal investigator, Pontificia Universidad Catolica de Chile, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985491
- Sponsor's protocol ID
- 08-1
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2009
- Last updated
- 15 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 22534421
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00985491
- Acronym / sponsor ID
- 08-1
- Conditions
- Obesity
- Keywords
- obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
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 the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Endobarrier LinerAll patients will be implanted with the Endobarrier Liner device. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobarrier LinerAlso: GI SleeveMedical device placed endoscopically in the duodenum | Device | Device |
Primary outcome
Assessment of % Excess Weight Loss
Time frame: 12 months
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).
1 secondary outcome
Improvement in Type 2 Diabetic Status
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22534421Escalona 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.
- Individual participant dataSharing planned: Yes
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex P Escalona, MD principal investigator
Pontificia Universidad Catolica de Chile, Santiago, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endobarrier Liner in people with Obesity, run by Morphic Medical Inc. at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of % Excess Weight Loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.