Lap-Band Surgery on Adolescents for Safety and Efficacy

NCT ID: NCT00587301

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2020-07-08

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

Conditions

Obesity; DM

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lap-Band

Lap-band surgery in treatment of morbidly obese adolescents

Group Type: EXPERIMENTAL

Lap-Band

Intervention Type: DEVICE

Obesity and adolescents

Interventions

Lap-Band

Obesity and adolescents

Intervention Type: DEVICE

Other Intervention Names

Lap-Band Adjustable Gastric Band (LAGB) Operation

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hope Foundation

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Ren-Fielding, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYUSOM

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://nyuweightloss.org

NYU Program for Surgical Weight Loss

Other Identifiers

G050010

Identifier Type: OTHER

Identifier Source: secondary_id

11876

Identifier Type: -

Identifier Source: org_study_id