Laparoscopic Adjustable Gastric Banding in Adolescents

NCT ID: NCT01619488

Last Updated: 2023-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-23

Study Completion Date

2016-04-04

Brief Summary

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This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Detailed Description

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This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Conditions

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Morbid Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric Banding

Surgical placement of an adjustable gastric band around the upper portion of the stomach.

Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.

Group Type EXPERIMENTAL

Adjustable Gastric Band

Intervention Type DEVICE

Surgical placement of an adjustable gastric band around the upper portion of the stomach.

Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.

Interventions

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Adjustable Gastric Band

Surgical placement of an adjustable gastric band around the upper portion of the stomach.

Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.

Intervention Type DEVICE

Other Intervention Names

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Lap-Band

Eligibility Criteria

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Inclusion Criteria

* ages 14-19
* BMI \> 35
* history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
* confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.

Exclusion Criteria

* history of congenital or acquired anomalies of the GI tract.
* history of esophageal motility disorders
* uncontrolled psychiatric problems
* previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
* uncontrolled eating disorders
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirk Reichard

OTHER

Sponsor Role lead

Responsible Party

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Kirk Reichard

OR SURGICAL DIRECTOR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kirk Reichard, MD

Role: PRINCIPAL_INVESTIGATOR

A I duPont Hospital for Children; Nemours Children's Clinic

Locations

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A I duPont Hospital for Children/Nemours Children's Clinic

Wilmington, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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0082295

Identifier Type: -

Identifier Source: org_study_id

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