Lap-Band Surgery on Adolescents for Safety and Efficacy

A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00587301

Acronym

ALAGB

Enrollment

119

Registered

2008-01-07

Start date

2005-06-30

Completion date

2020-07-08

Last updated

2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DM, Obesity

Keywords

Child Obesity

Brief summary

This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.

Detailed description

STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss. STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). DESIGN:Prospective, open-label, and single center

Interventions

DEVICELap-Band

Obesity and adolescents

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Be at least 14 and less than 18 years of age at the time of enrollment into the study. * Have a BMI of at least 40 * Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity. * Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol. Express willingness to follow protocol requirements. •Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.

Exclusion criteria

* Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement. * History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis. * Presence of dysphagia or documented esophageal dysmotility. * Patients with autoimmune connective tissue disorders * Patients with acute abdominal infections * Pregnancy or intention of becoming pregnant in the next 12 months. * Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol. * History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis. * Presence of localized or systemic infection at the time of surgery. * Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications. * History of gastric or esophageal surgery. * Use of weigh loss medications simultaneously

Design outcomes

Primary

Measure	Time frame
Percentage of Excess Weight Loss (EWL)	Year 1

Secondary

Measure	Time frame
Body Mass Index (BMI)	Year 1

Countries

United States

Participant flow

Participants by arm

Arm	Count
Lap-Band Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents	119
Total	119

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	22
Overall Study	Protocol Violation	7
Overall Study	Screen Failure	9
Overall Study	Withdrawal by Subject	7

Baseline characteristics

Characteristic	Lap-Band
Age, Continuous	16.1 years STANDARD_DEVIATION 1
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	13 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants
Race (NIH/OMB) White	90 Participants
Region of Enrollment United States	119 participants
Sex: Female, Male Female	79 Participants
Sex: Female, Male Male	40 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 119
other Total, other adverse events	99 / 119
serious Total, serious adverse events	24 / 119

Outcome results

Primary

Percentage of Excess Weight Loss (EWL)

Time frame: Year 1

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Percentage of Excess Weight Loss (EWL)	40.88 percentage of EWL	Standard Deviation 25.12

Primary

Percentage of Excess Weight Loss (EWL)

Time frame: Year 2

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Percentage of Excess Weight Loss (EWL)	44.18 percentage of EWL	Standard Deviation 26.36

Primary

Percentage of Excess Weight Loss (EWL)

Time frame: Year 3

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Percentage of Excess Weight Loss (EWL)	45.19 percentage of EWL	Standard Deviation 25.13

Primary

Percentage of Excess Weight Loss (EWL)

Time frame: Year 4

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Percentage of Excess Weight Loss (EWL)	42.96 percentage of EWL	Standard Deviation 26.3

Primary

Percentage of Excess Weight Loss (EWL)

Time frame: Year 5

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Percentage of Excess Weight Loss (EWL)	42.6 percentage of EWL	Standard Deviation 26.66

Secondary

Body Mass Index (BMI)

Time frame: Year 5

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Body Mass Index (BMI)	36.75 kg/m^2	Standard Deviation 8.98

Secondary

Body Mass Index (BMI)

Time frame: Year 1

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Body Mass Index (BMI)	37.67 kg/m^2	Standard Deviation 8.93

Secondary

Body Mass Index (BMI)

Time frame: Year 2

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Body Mass Index (BMI)	36.54 kg/m^2	Standard Deviation 9.1

Secondary

Body Mass Index (BMI)

Time frame: Year 3

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Body Mass Index (BMI)	36 kg/m^2	Standard Deviation 8.94

Secondary

Body Mass Index (BMI)

Time frame: Year 4

Arm	Measure	Value (MEAN)	Dispersion
Lap-Band	Body Mass Index (BMI)	36.39 kg/m^2	Standard Deviation 8.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Lap-Band Surgery on Adolescents for Safety and Efficacy

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Excess Weight Loss (EWL)

Percentage of Excess Weight Loss (EWL)

Percentage of Excess Weight Loss (EWL)

Percentage of Excess Weight Loss (EWL)

Percentage of Excess Weight Loss (EWL)

Body Mass Index (BMI)

Body Mass Index (BMI)

Body Mass Index (BMI)

Body Mass Index (BMI)

Body Mass Index (BMI)