ObesityPhase 2NCT01372501
Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
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 can be reimplanted. 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
- 19 participants
- Where
- 1 siteChile
- Study dates
- Sep 2010to Sep 2012
- 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
- 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.
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
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.
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 whether the the GI Endobarrier Liner can be reimplanted.
- 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 |
|---|---|---|
| Experimental: 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 the % Excess Weight Loss at Week 52 or Last Assessment
Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2
Measured: 52 Weeks
Secondary outcomes (1)
Change in Absolute Weight Loss From Baseline to Week 52
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionSep 2012
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.
- 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
- 19 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
- NCT01372501
- Sponsor's protocol ID
- 09-3
- Status last verified
- Dec 2016
- First submitted
- 10 Jun 2011
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual data is available on site at Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
- ClinicalTrials.gov ID
- NCT01372501
- Acronym / sponsor ID
- 09-3
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Posted 11 Mar 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 can be reimplanted.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: 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 (5 listed)
- 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.
Key exclusion criteria (22 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
- 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.
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 | Experimental: Device |
Primary outcome
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
1 secondary outcome
Change in Absolute Weight Loss From Baseline to Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data is available on site at Sponsor
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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 5 inclusion and 22 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 Feb 2017. 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 11 Mar 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 the % Excess Weight Loss at Week 52 or Last Assessment (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2017.