ObesityPhase 2/3NCT01060592
LapBand Adjustment to Improve Early Weight Loss
A Phase 2/3 study testing EndoFLIP device (FDA Device Listing Number : D091203) in people with Obesity, run by Crospon at 1 site in United States.
Trial summary
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- EndoFLIP device (FDA Device Listing Number : D091203)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing gastric band surgery
- Over 18 years of age
Who cannot join
- Actively bleeding varices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.
- Conditions
- Obesity
- Being tested
- EndoFLIP device (FDA Device Listing Number : D091203)
- Keywords
- Gastric Band, LapBand, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIP device (FDA Device Listing Number : D091203)Device
The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.
| Study group | Role | What they receive |
|---|---|---|
| Stoma Adjustment at Surgery | Experimental | The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment. Receives: Device: EndoFLIP device (FDA Device Listing Number : D091203) |
| Historic | No intervention | Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
Measured: 4-6 weeks post surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
Measured: 4-6 weeks post surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
Measured: 12m post surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Measured: 12m post surgery
Secondary outcomes (1)
Number of Band Adjustments Required in the First Year After Surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionMar 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crospon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert G Snow, DO FACOS, Principal investigator, AIGBJohn O'Dea, PhD, Study director, Crospon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060592
- Sponsor's protocol ID
- 2009-02
- Status last verified
- Apr 2013
- First submitted
- 30 Jan 2010
- Last updated
- 8 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
- ClinicalTrials.gov ID
- NCT01060592
- Acronym / sponsor ID
- 2009-02
- Conditions
- Obesity
- Keywords
- Gastric Band, LapBand, Bariatric Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CrosponIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stoma Adjustment at Surgery | Experimental | Device: EndoFLIP device (FDA Device Listing Number : D091203)The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment. |
| Historic | No intervention | –Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing gastric band surgery
- Over 18 years of age
Key exclusion criteria (1 listed)
- Actively bleeding varices
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 |
|---|---|---|
| EndoFLIP device (FDA Device Listing Number : D091203)The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm. | Device | Stoma Adjustment at Surgery |
Primary outcome
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
Time frame: 4-6 weeks post surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
Time frame: 4-6 weeks post surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
Time frame: 12m post surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Time frame: 12m post surgery
1 secondary outcome
Number of Band Adjustments Required in the First Year After Surgery
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSnow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12.
- Wellcome Trust funding announcementLink provided by 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.
Robert G Snow, DO FACOS principal investigator
AIGB
John O'Dea, PhD study director
Crospon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EndoFLIP device (FDA Device Listing Number : D091203) in people with Obesity, run by Crospon at 1 site 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 1 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 8 Apr 2013. 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Apr 2013). 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?
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) (time frame: 4-6 weeks post surgery). The study lists 4 primary outcomes in all. 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 NCT01060592, 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 8 Apr 2013.