ObesityPhase 2NCT00469391
Multi-Center Pre-Bariatric Weight Loss Study
A Phase 2 study testing GI Sleeve Implantable weight loss device (EndoBarrier) in people with Obesity, run by Morphic Medical Inc. at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- GI Sleeve Implantable weight loss device (EndoBarrier)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Oct 2008
- 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
- BMI > 35 with a significant comorbid condition or BMI 40-60
- Candidate for Bariatric Surgery
Who cannot join
- No pathologies of the GI Tract
- No anti-coagulant or non-steroidal anti-inflammatory medications
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Carolinas Medical Center
Charlotte, North Carolina, 28232
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cleveland Clinic Florida
Weston, Florida, 33331
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 efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
Read the detailed description
This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.
- Conditions
- Obesity
- Being tested
- GI Sleeve Implantable weight loss device (EndoBarrier), Sham Procedure
- Keywords
- Weight Reduction
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Sleeve Implantable weight loss device (EndoBarrier)Device
Also called endobarrier
device for weight loss
Sham ProcedureProcedure or surgery
Also called Sham
Weight loss
| Study group | Role | What they receive |
|---|---|---|
| GI Sleeve | Experimental | medical device that mimics gastric bypass mechanism for weight-loss Receives: Device: GI Sleeve Implantable weight loss device (EndoBarrier) |
| Sham Control | Sham comparator | Not described Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Excess Weight Loss (%EWL) at Week 12
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Tarnoff, MD, Study director, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469391
- Sponsor's protocol ID
- 06-3
- Status last verified
- Dec 2016
- First submitted
- 3 May 2007
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: De-identified individual patient data is on file at the 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 Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss
- ClinicalTrials.gov ID
- NCT00469391
- Acronym / sponsor ID
- 06-3
- Conditions
- Obesity
- Keywords
- Weight Reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Posted 30 Dec 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 the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
Detailed description
This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GI Sleeve | Experimental | Device: GI Sleeve Implantable weight loss device (EndoBarrier)medical device that mimics gastric bypass mechanism for weight-loss |
| Sham Control | Sham comparator | Procedure: Sham Procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 35 with a significant comorbid condition or BMI 40-60
- Candidate for Bariatric Surgery
Key exclusion criteria (2 listed)
- No pathologies of the GI Tract
- No anti-coagulant or non-steroidal anti-inflammatory medications
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 |
|---|---|---|
| GI Sleeve Implantable weight loss device (EndoBarrier)Also: endobarrierdevice for weight loss | Device | GI Sleeve |
| Sham ProcedureAlso: ShamWeight loss | Procedure or surgery | Sham Control |
Primary outcome
Percent Excess Weight Loss (%EWL) at Week 12
Time frame: 3 months
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
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: Undecided. De-identified individual patient data is on file at the 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.
Michael Tarnoff, MD study director
Tufts Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI Sleeve Implantable weight loss device (EndoBarrier) in people with Obesity, run by Morphic Medical Inc. at 4 sites in United States.
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 2 inclusion and 2 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 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 30 Dec 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?
Percent Excess Weight Loss (%EWL) at Week 12 (time frame: 3 months). 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.