NCT00543140

Brief Summary

The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

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

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 9, 2016

Completed
Last Updated

March 9, 2016

Status Verified

February 1, 2016

Enrollment Period

8.4 years

First QC Date

August 28, 2007

Results QC Date

January 11, 2016

Last Update Submit

February 9, 2016

Conditions

Morbid Obesity

Keywords

ObesityMorbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.

    A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device.

    5 years

Secondary Outcomes (4)

  • Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.

    5 years

  • Percent Change in Excess Body Weight at 5 Years Post-implant

    5 years

  • Change in SF-36 Health Survey Physical Component at 5 Years Post Implant

    5 years

  • Change in SF-36 Health Survey Mental Component at 5 Years Post Implant

    5 years

Study Arms (1)

REALIZE™ Swedish Adjustable Gastric Band

OTHER

All subjects have the REALIZE™ Swedish Adjustable Gastric Band. Single arm - no comparator.

Device: REALIZE™ Swedish Adjustable Gastric Band

Interventions

REALIZE™ Swedish Adjustable Gastric BandDEVICE

Laparoscopic placement of the Swedish Adjustable Gastric Band

Also known as: REALIZE Band
REALIZE™ Swedish Adjustable Gastric Band

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects eligible to participate in this study must fulfill all of the following criteria:
  • Able to comprehend, follow and give signed informed consent;
  • Consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity";
  • Currently have an SAGB implant in place;
  • Able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits; and
  • Living within the contiguous U.S.
  • Subjects eligible to participate in this study must fulfill all of the following criteria:
  • Able to comprehend, follow and give informed consent;
  • to 60 years of age (inclusive);
  • Body Mass Index (BMI) of \> 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and \< 40 kg/m2 with one or more co-morbid conditions.
  • Candidate for surgical weight loss intervention in accordance with the Instructions For Use (i.e., meets acceptable health criteria for major surgery).

You may not qualify if:

  • Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study:
  • a. Consented to, and participated in EES Protocol CI-02-0006 titled "A aSingle-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"; and have had the SAGB explanted.
  • Women who are currently pregnant.
  • Previous malabsorptive or restrictive procedures performed for the treatment of morbid obesity.
  • Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit (1a).
  • Presence of any of the following medical conditions;
  • Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
  • Severe cardiopulmonary disease or other serious organic disease;
  • Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
  • Portal hypertension;
  • Anomalies of the gastrointestinal tract such as atresia or stenosis;
  • Cirrhosis of the liver;
  • Chronic pancreatitis;
  • Patients on chronic, long-term steroid treatment or steroids within 15 days of surgery;
  • Unable or unwilling to comply with dietary restrictions required by this procedure;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Surgical Associates of La Jolla Medical Group, Inc.

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Advanced Surgical Institute at Mercy Hospital

Miami, Florida, 33133, United States

Location

Robert T. Marema, MD

Saint Augustine, Florida, 32086, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Hamilton Medical Center - Weight Management

Dalton, Georgia, 30722, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Michael Schwiers, Principal Biostatistician
Organization
Ethicon Endo-Surgery
mschwier@its.jnj.com
513-337-1172

Study Officials

  • Edward Phillips, MD

    Cedars Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

October 12, 2007

Study Start

August 1, 2006

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 9, 2016

Results First Posted

March 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD. Cumulative data from the study will be published.

Locations

US(8)