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CompletedNCT00587301ALAGBUpdated Mar 22, 2022Results posted

Lap-Band Surgery on Adolescents for Safety and Efficacy

An interventional study of Lap-Band in Obesity and DM, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 14 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Not applicable
Ages
14 Years to 17 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Obesity
  • DM

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Keywords

  • Child Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 119 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    Lap-Band

    Lap-band surgery in treatment of morbidly obese adolescents

    Device: Lap-Band

Interventions

  • DeviceLap-Band

    Obesity and adolescents

    Also known as: Lap-Band Adjustable Gastric Band (LAGB) Operation

06

What researchers measure

Primary outcomes

  1. Percentage of Excess Weight Loss (EWL)

    Time frame: Year 1

  2. Percentage of Excess Weight Loss (EWL)

    Time frame: Year 2

  3. Percentage of Excess Weight Loss (EWL)

    Time frame: Year 3

  4. Percentage of Excess Weight Loss (EWL)

    Time frame: Year 4

  5. Percentage of Excess Weight Loss (EWL)

    Time frame: Year 5

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: Year 1

  2. Body Mass Index (BMI)

    Time frame: Year 2

  3. Body Mass Index (BMI)

    Time frame: Year 3

  4. Body Mass Index (BMI)

    Time frame: Year 4

  5. Body Mass Index (BMI)

    Time frame: Year 5

07

Results

Posted Mar 22, 2022

Participant flow

Participant flow — Overall Study
MilestoneLap-Band
Started119
Completed74
Not completed45
Withdrew: Screen failure9
Withdrew: Lost to follow-up22
Withdrew: Withdrawal by subject7
Withdrew: Protocol violation7

Outcome measures

PrimaryPercentage of Excess Weight Loss (EWL)
Time frame:
Year 1
Reported as:
Mean · percentage of EWL
Percentage of Excess Weight Loss (EWL)
percentage of EWLLap-Band
Percentage of Excess Weight Loss (EWL)40.88 ± 25.12
SecondaryBody Mass Index (BMI)
Time frame:
Year 1
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Lap-Band
Body Mass Index (BMI)37.67 ± 8.93
PrimaryPercentage of Excess Weight Loss (EWL)
Time frame:
Year 2
Reported as:
Mean · percentage of EWL
Percentage of Excess Weight Loss (EWL)
percentage of EWLLap-Band
Percentage of Excess Weight Loss (EWL)44.18 ± 26.36
PrimaryPercentage of Excess Weight Loss (EWL)
Time frame:
Year 3
Reported as:
Mean · percentage of EWL
Percentage of Excess Weight Loss (EWL)
percentage of EWLLap-Band
Percentage of Excess Weight Loss (EWL)45.19 ± 25.13
PrimaryPercentage of Excess Weight Loss (EWL)
Time frame:
Year 4
Reported as:
Mean · percentage of EWL
Percentage of Excess Weight Loss (EWL)
percentage of EWLLap-Band
Percentage of Excess Weight Loss (EWL)42.96 ± 26.30
PrimaryPercentage of Excess Weight Loss (EWL)
Time frame:
Year 5
Reported as:
Mean · percentage of EWL
Percentage of Excess Weight Loss (EWL)
percentage of EWLLap-Band
Percentage of Excess Weight Loss (EWL)42.6 ± 26.66
SecondaryBody Mass Index (BMI)
Time frame:
Year 2
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Lap-Band
Body Mass Index (BMI)36.54 ± 9.10
SecondaryBody Mass Index (BMI)
Time frame:
Year 3
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Lap-Band
Body Mass Index (BMI)36 ± 8.94
SecondaryBody Mass Index (BMI)
Time frame:
Year 4
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Lap-Band
Body Mass Index (BMI)36.39 ± 8.9
SecondaryBody Mass Index (BMI)
Time frame:
Year 5
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Lap-Band
Body Mass Index (BMI)36.75 ± 8.98

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lap-Band0/119 (0%)24/119 (20.2%)99/119 (83.2%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventLap-Band
Band slippageGastrointestinal disorders12/119
CholelithiasisGastrointestinal disorders2/119
Port leakGeneral disorders2/119
Pregnancy with abortionPregnancy, puerperium and perinatal conditions2/119
Abdominal pannus (excess skin)Gastrointestinal disorders1/119
Band erosionGastrointestinal disorders1/119
CholecystitisGastrointestinal disorders1/119
Cholelithiasis (Aggravated)Gastrointestinal disorders1/119
Esophageal and gastric pouch dilatationGastrointestinal disorders1/119
Gastric pouch dilatationGastrointestinal disorders1/119
Most frequent other events
Showing 10 of 135
Most frequent other events
EventLap-Band
Low Vit. D levelGeneral disorders40/119
Low iron levelGeneral disorders31/119
Hair ThinningGeneral disorders29/119
Esophageal dilatationGeneral disorders23/119
HeartburnGastrointestinal disorders17/119
RefluxGastrointestinal disorders17/119
Gastric pouch dilatationGastrointestinal disorders16/119
Low Vit. D level (Aggravated)General disorders12/119
Band slippageGastrointestinal disorders9/119
Abdominal painGastrointestinal disorders7/119

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lap-Band
Mean16.1 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)Lap-Band
Female79
Male40
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lap-Band
Hispanic or Latino11
Not Hispanic or Latino108
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lap-Band
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American13
White90
More than one race0
Unknown or Not Reported15
Region of Enrollment
Region of Enrollment(participants)Lap-Band
United States119
08

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 10, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00587301
Lead sponsor
NYU Langone Health
Collaborators
Hope Foundation
Responsible party
Sponsor
First posted
Jan 7, 2008
Start date
Jun 2005
Primary completion
Jul 8, 2020
Completion
Jul 8, 2020
Results posted
Mar 22, 2022
Last update
Mar 22, 2022

Study contacts

Christine Ren-Fielding, M.D.
principal investigator · NYUSOM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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