NCT01882049

Brief Summary

This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 20, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
2.9 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

November 20, 2012

Last Update Submit

May 12, 2016

Conditions

OBESITY

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Reduction in percent of excess weight loss (%EWL).

    Monthly up to one year

Study Arms (1)

Treatment

EXPERIMENTAL

Use of Realize gastric band (Ethicon) in adolescents for weight reduction

Device: REALIZE Gastric band (ETHICON)

Interventions

REALIZE Gastric band (ETHICON)DEVICE

Placement of gastric band around upper stomach

Treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5

You may not qualify if:

  • Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
  • Hyperlipidemia: hyperlipidemia depends on
  • Obstructive Sleep Apnea:
  • Metabolic Syndrom: The presence of any three of the following: abdominal obesity - dimensons for children? triglycerides -cholesterol -
  • fasting glucose
  • blood pressure
  • overweight
  • Non-surgical means of weight reduction failure of
  • Significant psychopathology (absence of ) that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment;
  • Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for three years following SAGB placement; and
  • Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sayeed Ikrammudin, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

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

November 20, 2012

First Posted

June 20, 2013

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

US(1)