NCT00587301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 22, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

15.1 years

First QC Date

December 21, 2007

Results QC Date

January 4, 2022

Last Update Submit

March 21, 2022

Conditions

ObesityDM

Keywords

Child Obesity

Outcome Measures

Primary Outcomes (5)

  • Percentage of Excess Weight Loss (EWL)

    Year 1

  • Percentage of Excess Weight Loss (EWL)

    Year 2

  • Percentage of Excess Weight Loss (EWL)

    Year 3

  • Percentage of Excess Weight Loss (EWL)

    Year 4

  • Percentage of Excess Weight Loss (EWL)

    Year 5

Secondary Outcomes (5)

  • Body Mass Index (BMI)

    Year 1

  • Body Mass Index (BMI)

    Year 2

  • Body Mass Index (BMI)

    Year 3

  • Body Mass Index (BMI)

    Year 4

  • Body Mass Index (BMI)

    Year 5

Study Arms (1)

Lap-Band

EXPERIMENTAL

Lap-band surgery in treatment of morbidly obese adolescents

Device: Lap-Band

Interventions

Lap-BandDEVICE

Obesity and adolescents

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

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Links

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christine Ren Fielding, MD
Organization
NYU Langone Health
christine.ren-fielding@nyulangone.org
2122633166

Study Officials

  • Christine Ren-Fielding, M.D.

    NYUSOM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

June 1, 2005

Primary Completion

July 8, 2020

Study Completion

July 8, 2020

Last Updated

March 22, 2022

Results First Posted

March 22, 2022

Record last verified: 2022-03

Locations

US(1)