An observational study in Obesity, Morbid, sponsored by Apollo Endosurgery, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by Apollo Endosurgery, Inc. · Observational
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 521 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Apollo Endosurgery, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community sample
Exclusion Criteria:
Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
Device: LAP-BAND AP Adjustable Gastric Banding System
Reduction of food intake due to creation of smaller stomach pouch.
Change in Percent Excess Weight
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
Time frame: Baseline to 5 Years
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
Time frame: Baseline to 5 years
Subject Reported Satiety
Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
Time frame: Baseline to 5 Years
Subject Reported Quality of Life
Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
Time frame: Baseline to 5 Years
Subject Reported Sleepiness (Epworth Sleepiness Scale)
The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).
Time frame: Baseline to 5 years
| Milestone | LAP-BAND |
|---|---|
| Started | 515 |
| Completed | 83 |
| Not completed | 432 |
| Withdrew: Lost to follow-up | 195 |
| Withdrew: Withdrawal by subject | 34 |
| Withdrew: Subject decision | 1 |
| Withdrew: Revision surgery | 7 |
| Withdrew: Explantation surgery | 26 |
| Withdrew: Adverse event | 4 |
| Withdrew: Non-compliance | 24 |
| Withdrew: Study closed by sponsor | 109 |
| Withdrew: Other loss to follow-up | 32 |
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
| percentage of excess weight lost | LAP-BAND |
|---|---|
| %EWL from baseline 48 Weeks Post-Surgery (n=402) | -45.7 ± 21.26 |
| %EWL from baseline 24 Months Post-Surgery (n=304) | -50.8 ± 26.70 |
| %EWL from baseline 36 Months Post-Surgery (n=226) | -47.7 ± 30.21 |
| %EWL from baseline 48 Months Post-Surgery (n=156) | -46.5 ± 27.23 |
| %EWL from baseline 60 Months Post-Surgery (n=84) | -45.9 ± 26.80 |
Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
| kg/m2 | LAP-BAND |
|---|---|
| BMI at 48 Weeks Post-Surgery (n=402) | 35.9 ± 6.39 |
| BMI at 24 Months Post-Surgery (n=304) | 34.8 ± 6.49 |
| BMI at 36 Months Post-Surgery (n=226) | 35.2 ± 6.98 |
| BMI at 48 Months Post-Surgery (n=156) | 35.1 ± 6.20 |
| BMI at 60 Months Post-Surgery (n=84) | 35.2 ± 6.49 |
Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
| units on a scale | LAP-BAND |
|---|---|
| Level of Hunger at Baseline (n=487) | 2.1 ± 1.21 |
| Level of Hunger at Month 60 (n=81) | 2.3 ± 1.18 |
| Level of Fullness at Baseline (n=488) | 3.5 ± 1.19 |
| Level of Fullness at Month 60 (n=81) | 3.3 ± 1.29 |
| Level of Desire to Eat at Baseline (n=488) | 2.4 ± 1.19 |
| Level of Desire to Eat at Month 60 (n=81) | 2.7 ± 1.19 |
Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
| units on a scale | LAP-BAND |
|---|---|
| OWL-QOL-17 Score at Baseline (n=496) | 69.8 ± 19.98 |
| OWL-QOL-17 Score at Month 60 (n=74) | 34.5 ± 24.50 |
The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).
| units on a scale | LAP-BAND |
|---|---|
| Reported Sleepiness at Baseline (n=498) | 8.0 ± 4.23 |
| Reported Sleepiness at Month 60 (n=79) | 5.0 ± 3.21 |
Collected over Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LAP-BAND | — | 38/515 (7.4%) | 158/515 (30.7%) |
| Event | LAP-BAND |
|---|---|
| Band SlipSurgical and medical procedures | 15/515 |
| Abdominal painGastrointestinal disorders | 5/515 |
| DehydrationMetabolism and nutrition disorders | 4/515 |
| Band erosionSurgical and medical procedures | 3/515 |
| Band removalSurgical and medical procedures | 3/515 |
| Fibrous Band ObstructionGeneral disorders | 2/515 |
| DeathGeneral disorders | 1/515 |
| Device MalfunctionGeneral disorders | 1/515 |
| DysphagiaGastrointestinal disorders | 1/515 |
| Gastric ErosionGastrointestinal disorders | 1/515 |
| Event | LAP-BAND |
|---|---|
| Vomiting/NauseaGastrointestinal disorders | 42/515 |
| DysphagiaGastrointestinal disorders | 37/515 |
| Gastroesophageal Reflux Disease (GERD)Gastrointestinal disorders | 13/515 |
| Dilated Gastric PouchGastrointestinal disorders | 12/515 |
| HeartburnGastrointestinal disorders | 11/515 |
| Band too tightGeneral disorders | 9/515 |
| Acid RefluxGastrointestinal disorders | 8/515 |
| Increased RestrictionGastrointestinal disorders | 7/515 |
| Pain at port siteGeneral disorders | 7/515 |
| Flipped PortGeneral disorders | 6/515 |
The analysis population is defined as the number of subjects who underwent treatment with the LAP-BAND System.
| Age, Continuous(years) | LAP-BAND |
|---|---|
| Mean | 42.7 ± 10.89 |
| Age, Customized(years) | LAP-BAND |
|---|---|
| Median Age | 42.7 (18.5 to 70.6) |
| Sex: Female, Male(Participants) | LAP-BAND |
|---|---|
| Female | 422 |
| Male | 93 |
| Race/Ethnicity, Customized(participants) | LAP-BAND |
|---|---|
| Asian | 0 |
| Black | 52 |
| Hispanic | 16 |
| Caucasian | 443 |
| Other (Native American or unspecified) | 3 |
| Missing | 1 |
| Baseline Weight(pounds (lbs)) | LAP-BAND |
|---|---|
| Mean | 273.9 ± 51.37 |
| Body Mass Index (BMI) at Baseline(kg/m2) | LAP-BAND |
|---|---|
| Mean | 44.0 ± 6.25 |
| Baseline Excess Weight(pounds (lbs)) | LAP-BAND |
|---|---|
| Mean | 118.7 ± 42.46 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Apollo Endosurgery, Inc.