ObesityNCT01661608
Gastric Restriction Using the EndoSurgical Operating System
A study testing Using the EOS for gastric restriction in people with Obesity, run by USGI Medical at 5 sites in 2 countries.
Trial summary
The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Using the EOS for gastric restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
- Patient is >/= 20 yrs. of age and </= 60 yrs. of age
- Patient has a BMI of >/=30 and < 40
- Patient has history of obesity for >/= 2 yrs.
- Patient has had not significant weight change (<5% of total body weight) in last 6 months.
- Patient is a reasonable candidate for general anesthesia
- Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.
Who cannot join
- Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
- Patient is not able to provide written informed consent
- Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
- Patient has diabetes secondary to a specific disease.
- Patient has history of inflammatory disease of GI tract
- Patient has diabetic retinopathy
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- Patient has chronic pancreatic disease
- Patient ahs active peptic ulcer
- Patient has portal hypertension
- Patient has esophageal varices
- Patient has significant esophageal disease
- Patient has a history of any significant abdominal surgery
- Patient has a history of any bariatric or GERD surgical procedures
- Patient has a hiatal hernia > 2cm.
- Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
- Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
- Patient has cancer or life expectancy of < 2 yrs.
- Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
- Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
- Patient has a history of durg or alcohol abuse
- Patient has uncontrolled depression, psychosis, or eating disorder.
- Patient is non-ambulatory or has significant impairment of mobility.
- Patient has known hormonal or genetic cause for obesity.
- Patient is participating in another Registry and/or Study that could adversely affect this Registry.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Brigham & Womens
Boston, Massachusetts
Presbyterian
Charlotte, North Carolina
Bluegrass
Lexington, Kentucky
SSL
New Orleans, Louisiana
About this study
The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.
- Conditions
- Obesity
- Being tested
- Using the EOS for gastric restriction
- Keywords
- Gastric Restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the EOS for gastric restrictionDevice
| Study group | Role | What they receive |
|---|---|---|
| EOS | Experimental | Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures Receives: Device: Using the EOS for gastric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation in regards to Weight Loss
Measured: 24 Months Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: FDA indicated study should have had prior IDE submission \& approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J. Thomas, MD, FACS, Principal investigator, SSLThomas Lavin, MD, Principal investigator, SSLDavid Voelinger, MD, Principal investigator, PresbyterianPeter Denk, MD, Principal investigator, BluegrassChristopher Thompson, MD, Principal investigator, Brigham & WomansSantiago Horgan, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661608
- Sponsor's protocol ID
- TPR41122
- Status last verified
- Aug 2012
- First submitted
- 7 Aug 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Restriction Using the EndoSurgical Operating System
- ClinicalTrials.gov ID
- NCT01661608
- Acronym / sponsor ID
- TPR41122
- Conditions
- Obesity
- Keywords
- Gastric Restriction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA indicated study should have had prior IDE submission \& approval
- Enrolment
- 32 participants (actual)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOS | Experimental | Device: Using the EOS for gastric restrictionCollecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
- Patient is >/= 20 yrs. of age and </= 60 yrs. of age
- Patient has a BMI of >/=30 and < 40
- Patient has history of obesity for >/= 2 yrs.
- Patient has had not significant weight change (<5% of total body weight) in last 6 months.
Key exclusion criteria (25 listed)
- Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
- Patient is not able to provide written informed consent
- Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
- Patient has diabetes secondary to a specific disease.
- Patient has history of inflammatory disease of GI tract
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 |
|---|---|---|
| Using the EOS for gastric restriction | Device | EOS |
Primary outcome
Clinical Evaluation in regards to Weight Loss
Time frame: 24 Months Post-op
Results and safety
The study was stopped early (reason given: FDA indicated study should have had prior IDE submission \& approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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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 J. Thomas, MD, FACS principal investigator
SSL
Thomas Lavin, MD principal investigator
SSL
David Voelinger, MD principal investigator
Presbyterian
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the EOS for gastric restriction in people with Obesity, run by USGI Medical at 5 sites in 2 countries.
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 25 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: stopped early, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Mexico. 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?
The study was stopped early (reason given: FDA indicated study should have had prior IDE submission \& approval). Results are not available in the source record.
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?
Clinical Evaluation in regards to Weight Loss (time frame: 24 Months Post-op). 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 9 Aug 2012.