ObesityNCT00830440
A Multicenter Study for Pre-Surgical Weight Loss
A study testing EndoBarrier Device and Diet & Lifestyle Counseling in people with Obesity, run by Morphic Medical Inc. at 1 site in Netherlands.
Trial summary
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery. It is a randomized, prospective controlled, open label, pilot study of 40 patients. 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 Device and Diet & Lifestyle Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2007to Sep 2008
- Phase
- Interventional
- 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
- Patients willing to comply with study requirements
- Patients who have signed an informed consent form
Who cannot join
- Patients requiring prescription anticoagulation therapy
- Patients with iron deficiency and iron deficiency anemia
- Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Treatment represents an unreasonable risk to the patient
- Pancreatitis or other serious organic conditions
- Symptomatic coronary artery disease or pulmonary dysfunction
Show all 23Show fewer
- Patients with known gallstones prior to implant
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- Pregnant or has the intention of becoming pregnant in the next 12 months
- Unresolved alcohol or drug addiction
- HIV Positive patients
- Patients with hepatitis B or C
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
- Previous GI surgery that could affect the ability to place the sleeve or the function of the implant.
- Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
- Patients receiving weight loss medications such as Meridia and Xenical
- Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Patients with gastroesophageal reflux disease (GERD)
- Patients with a history of kidney stones
- Participating in another ongoing investigational clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.
It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.
Read more
The primary efficacy endpoint is:
- Assessment of the difference in % excess weight loss between the 2 groups
Secondary endpoints are:
- Resolution or Improvement in type II Diabetic status as defined as:
- Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
- Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
- The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.
- Conditions
- Obesity
- Being tested
- EndoBarrier Device, Diet & Lifestyle Counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrier DeviceDevice
Also called EndoBarrier Gastrointestinal Liner
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
Diet & Lifestyle CounselingBehavioural
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier Device | Experimental | EndoBarrier Device and Diet \& Lifestyle Counseling Receives: Device: EndoBarrier Device; Behavioral: Diet & Lifestyle Counseling |
| Control | Active comparator | Diet \& Lifestyle Counseling Receives: Behavioral: Diet & Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weight Change From Baseline at 12 Weeks in kg
Measured: 12 weeks
Secondary outcomes (2)
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks
The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.
Measured: 12 weeks
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12
Measured: Baseline to Week 12 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionSep 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jan Willem Greve, Morphic Medical Inc.
- Investigators
- Jan Willem Greve, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830440
- Sponsor's protocol ID
- 06-4
- Status last verified
- Apr 2017
- First submitted
- 26 Jan 2009
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.
PubMed 19858703
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
- ClinicalTrials.gov ID
- NCT00830440
- Acronym / sponsor ID
- 06-4
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Posted 10 Apr 2017
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 the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.
It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.
The primary efficacy endpoint is:
- Assessment of the difference in % excess weight loss between the 2 groups
Secondary endpoints are:
- Resolution or Improvement in type II Diabetic status as defined as:
- Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
- Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
- The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier Device | Experimental | Device: EndoBarrier Device, Behavioral: Diet & Lifestyle CounselingEndoBarrier Device and Diet \& Lifestyle Counseling |
| Control | Active comparator | Behavioral: Diet & Lifestyle CounselingDiet \& Lifestyle Counseling |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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
- Patients willing to comply with study requirements
Key exclusion criteria (23 listed)
- Patients requiring prescription anticoagulation therapy
- Patients with iron deficiency and iron deficiency anemia
- Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Treatment represents an unreasonable risk to the patient
- Pancreatitis or other serious organic conditions
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 DeviceAlso: EndoBarrier Gastrointestinal LinerNIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks | Device | EndoBarrier Device |
| Diet & Lifestyle CounselingNIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp | Behavioural | Control, EndoBarrier Device |
Primary outcome
Total Weight Change From Baseline at 12 Weeks in kg
Time frame: 12 weeks
2 secondary outcomes
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks
Time frame: 12 weeks
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12
Time frame: Baseline to Week 12 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19858703Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.
- Individual participant dataSharing planned: No
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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.
Jan Willem Greve, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoBarrier Device and Diet & Lifestyle Counseling in people with Obesity, run by Morphic Medical Inc. at 1 site in Netherlands.
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 6 inclusion and 23 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 17 May 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 Netherlands. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). 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?
Total Weight Change From Baseline at 12 Weeks in kg (time frame: 12 weeks). 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 NCT00830440, 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 17 May 2017.