Morbid Obesity
Conditions
Keywords
Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band
Brief summary
The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.
Interventions
DEVICEIntraband pressure recording system
Intraband pressure will be measured by a pressure recording system.
OTHERConventional Adjustment
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to comprehend, follow and give informed consent. * Be at least 18 years of age at time of trial enrollment. * Had a pre-implantation BMI between 35 and 55 kg/m2. * Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment yet)prior to the date of enrollment. * Willingness to be randomized to intraband-based or conventional adjustments * Willingness to consent to monthly visits and possible measurements of intraband pressure (requiring access to the injection port). * Willingness to undergo up to 7 band adjustments within the 6-month period of the study. * Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements. * Willingness to return to office visits around the same time of the first in-study adjustment (plus or minus 2 hours) * Willingness to consent to a limited UGI series if the investigator suspects the presence of a band-related complication or if the intraband pressure recordings deviate from expected. * Willingness to refrain from taking medications or supplements indicated for or known to induce weight loss.
Exclusion criteria
* Females currently known to be pregnant. * Ongoing or unresolved band perforation or band leakage. * Ongoing (unresolved) slippage, erosion, or pouch dilation. * Documented esophageal dysmotility/dyskinesia. * Ongoing (unresolved) port obstruction or tube kinking. * Current injection port infection. * History of band revision or replacement. * Previously documented or ongoing esophageal dilatation. * Any condition that, in the opinion of the Investigator, may jeopardize the subject's well-being or the soundness of this study. * Current use of medications or supplements indicated for or known to induce weight loss at any point during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Excess Weight Change at Day 180 | Screening to Day 180 | Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Static Intraband Pressure at Day 180 | Day 180 | Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition) |
| Rate of Weight Loss kg/wk at Day 180 | Screening to Day 180 | Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7). |
Countries
Australia, Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Adjustment Group Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). | 25 |
| Intraband Pressure Arm Subjects whose band adjustments will be guided by intraband pressure readings. | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Repeated needle dislodgment | 0 | 1 |
Baseline characteristics
| Characteristic | Conventional Adjustment Group | Intraband Pressure Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 25 Participants | 49 Participants |
| Age Continuous | 47.2 years STANDARD_DEVIATION 11.93 | 45.1 years STANDARD_DEVIATION 12.69 | 46.1 years STANDARD_DEVIATION 12.25 |
| Region of Enrollment Australia | 13 participants | 14 participants | 27 participants |
| Region of Enrollment Czech Republic | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 25 | 11 / 26 |
| serious Total, serious adverse events | 0 / 25 | 1 / 26 |
Outcome results
Primary
Percent Excess Weight Change at Day 180
Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.
Time frame: Screening to Day 180
Population: Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Arm | Percent Excess Weight Change at Day 180 | -13.2 percentage of excess weight at screening | Standard Deviation 11.1 |
| Intraband Pressure Arm | Percent Excess Weight Change at Day 180 | -24.2 percentage of excess weight at screening | Standard Deviation 17.5 |
Comparison: Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.p-value: 0.052t-test, 2 sided
Secondary
Mean Static Intraband Pressure at Day 180
Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)
Time frame: Day 180
Population: Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Arm | Mean Static Intraband Pressure at Day 180 | 0.7 mmHg | Standard Deviation 7.03 |
| Intraband Pressure Arm | Mean Static Intraband Pressure at Day 180 | 15.8 mmHg | Standard Deviation 17.82 |
p-value: 0.0225t-test, 2 sided
Secondary
Rate of Weight Loss kg/wk at Day 180
Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).
Time frame: Screening to Day 180
Population: Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Arm | Rate of Weight Loss kg/wk at Day 180 | 0.18 kg/week | Standard Deviation 0.1 |
| Intraband Pressure Arm | Rate of Weight Loss kg/wk at Day 180 | 0.43 kg/week | Standard Deviation 0.32 |
p-value: 0.0193t-test, 2 sided