Lap-Band Surgery on Adolescents for Safety and Efficacy

Obesity Clinical Trial

— ALAGB  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587301
• Other study ID #: 11876
• Secondary ID: G050010
• Status: Completed
• Phase: N/A
• Start date: June 2005
• Est. completion date: July 8, 2020

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• DM
• Obesity

Intervention

Device:
• Lap-Band
Obesity and adolescents

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Hope Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Excess Weight Loss (EWL)		Year 1
Primary	Percentage of Excess Weight Loss (EWL)		Year 2
Primary	Percentage of Excess Weight Loss (EWL)		Year 3
Primary	Percentage of Excess Weight Loss (EWL)		Year 4
Primary	Percentage of Excess Weight Loss (EWL)		Year 5
Secondary	Body Mass Index (BMI)		Year 1
Secondary	Body Mass Index (BMI)		Year 2
Secondary	Body Mass Index (BMI)		Year 3
Secondary	Body Mass Index (BMI)		Year 4
Secondary	Body Mass Index (BMI)		Year 5

External Links

•   NYU Program for Surgical Weight Loss