Obesity
Conditions
Keywords
Gastric Band, LapBand, Bariatric Surgery
Brief 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 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.
Interventions
DEVICEEndoFLIP 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.
Sponsors
Crospon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing gastric band surgery * Over 18 years of age
Exclusion criteria
* Actively bleeding varices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) | 4-6 weeks post surgery |
| %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) | 4-6 weeks post surgery |
| % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) | 12m post surgery |
| % Excess Weight Loss 12 Months After Surgery (Small Bands Only) | 12m post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Number of Band Adjustments Required in the First Year After Surgery | 12 months |
Countries
United States
Participant flow
Recruitment details
35 pts recruited between Oct 2009 and Jan 2010
Pre-assignment details
N/A - Single arm non-randomized study
Participants by arm
| Arm | Count |
|---|---|
| Historic Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records | 49 |
| Stoma Adjustment at Surgery The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery | 35 |
| Total | 84 |
Baseline characteristics
| Characteristic | Historic | Stoma Adjustment at Surgery | Total |
|---|---|---|---|
| Age Continuous | 43.0 years STANDARD_DEVIATION 11.6 | 40.1 years STANDARD_DEVIATION 11.6 | 42.8 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 49 participants | 35 participants | 84 participants |
| Sex: Female, Male Female | 36 Participants | 28 Participants | 64 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 35 |
| serious Total, serious adverse events | 0 / 49 | 0 / 35 |
Outcome results
Primary
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
Time frame: 12m post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Historic | % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) | 48.3 %EWL | Standard Deviation 15 |
| Stoma Adjustment at Surgery | % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) | 50.4 %EWL | Standard Deviation 24.5 |
Primary
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Time frame: 12m post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Historic | % Excess Weight Loss 12 Months After Surgery (Small Bands Only) | 48.71 %EWL | Standard Deviation 15.61 |
| Stoma Adjustment at Surgery | % Excess Weight Loss 12 Months After Surgery (Small Bands Only) | 60.32 %EWL | Standard Deviation 22.77 |
Primary
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
Time frame: 4-6 weeks post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Historic | %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) | 15.63 %EWL | Standard Deviation 8.9 |
| Stoma Adjustment at Surgery | %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) | 20.8 %EWL | Standard Deviation 10.8 |
Primary
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
Time frame: 4-6 weeks post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Historic | %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) | 16.33 %EWL | Standard Deviation 9.54 |
| Stoma Adjustment at Surgery | %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) | 23.07 %EWL | Standard Deviation 11.59 |
Secondary
Number of Band Adjustments Required in the First Year After Surgery
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Historic | Number of Band Adjustments Required in the First Year After Surgery | 6.47 Number of Adjustments | Standard Deviation 3.15 |
| Stoma Adjustment at Surgery | Number of Band Adjustments Required in the First Year After Surgery | 6.66 Number of Adjustments | Standard Deviation 2.9 |