ObesityPhase 1TRIMNCT00679848
Transoral Gastric Volume Reduction as an Intervention for Weight Management
A Phase 1 study testing RS2 (RESTORe Suturing System) in people with Obesity, run by C. R. Bard at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- RS2 (RESTORe Suturing System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Nov 2010
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male, Female; ages >18yrs - £ 60 yrs
- BMI 30-45 kg/m2
- History of obesity for 5 yrs; attempts at weight control ineffective
- Weight stable
- Willing to comply with study requirements
- Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
- Sign informed consent form
Who cannot join
- Women of childbearing age not practicing effective birth control method or pregnant or lactating
- Mallampati score = 4
- Uncontrolled hypothyroidism
- Previous interventional/surgical treatment of obesity; any prior gastric surgery
- History of diabetes for > 10 yrs or difficult to control diabetes
- Presence of hiatal hernia
Show all 18Show fewer
- Congenital or acquired anomalies of the GI tract
- Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
- Chronic or acute upper gastrointestinal bleeding conditions
- Helicobacter pylori positive
- Immunocompromised
- Subjects with eating disorders
- Acute or chronic infection
- Significant movement limitations
- Not a candidate for conscious or general anesthesia
- Active substance abuse
- Life expectancy < 2 years
- Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System
- Conditions
- Obesity
- Being tested
- RS2 (RESTORe Suturing System)
- Keywords
- Weight Loss, Transoral Suturing, Experimental
- 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.
RS2 (RESTORe Suturing System)Device
Suturing in stomach
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transoral Suturing Receives: Device: RS2 (RESTORe Suturing System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 24 Months
Secondary outcomes (1)
Technical success of test procedure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionNov 2010
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.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679848
- Sponsor's protocol ID
- DVL-EC-003
- Acronym
- TRIM
- Status last verified
- Jan 2017
- First submitted
- 13 May 2008
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
- ClinicalTrials.gov ID
- NCT00679848
- Acronym / sponsor ID
- TRIM / DVL-EC-003
- Conditions
- Obesity
- Keywords
- Weight Loss, Transoral Suturing, Experimental
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 May 2008 (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 purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: RS2 (RESTORe Suturing System)Transoral Suturing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male, Female; ages >18yrs - £ 60 yrs
- BMI 30-45 kg/m2
- History of obesity for 5 yrs; attempts at weight control ineffective
- Weight stable
- Willing to comply with study requirements
Key exclusion criteria (18 listed)
- Women of childbearing age not practicing effective birth control method or pregnant or lactating
- Mallampati score = 4
- Uncontrolled hypothyroidism
- Previous interventional/surgical treatment of obesity; any prior gastric surgery
- History of diabetes for > 10 yrs or difficult to control diabetes
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 |
|---|---|---|
| RS2 (RESTORe Suturing System)Suturing in stomach | Device | 1 |
Primary outcome
Weight Loss
Time frame: 24 Months
1 secondary outcome
Technical success of test procedure.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RS2 (RESTORe Suturing System) in people with Obesity, run by C. R. Bard at 2 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 7 inclusion and 18 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Loss (time frame: 24 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 11 Jan 2017.