Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00166205
First received: September 9, 2005
Last updated: January 23, 2009
Last verified: December 2008
  Purpose

The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB) is safe, and effective in achieving weight loss in patients with Morbid Obesity.


Condition Intervention Phase
Obesity, Morbid
Device: Swedish Adjustable Gastric Band
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Percent Excess Weight Loss [ Time Frame: 3 Years Post Operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Excess Body Weight (EBW) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Body Mass Index (BMI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in Absolute Weight [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Quality of Life (QOL) Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of All Adverse Events of Subjects Implanted With the SAGB [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • Changes in High Density Lipoproteins (HDL) [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Changes in Low Density Lipoproteins (LDL) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Total Cholesterol [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: June 2003
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: Gastric Band
Single-arm study, all subjects banded.
Device: Swedish Adjustable Gastric Band
Long term implantable device.
Other Names:
  • Swedish Adjustable Gastric Band
  • Realize Band

Detailed Description:

Surgical treatment of morbidly obese patients is considered a reasonable option for achieving weight loss when more conservative measures, such as diet and exercise have failed. Not only can weight loss be achieved, but also reduction / resolution of a patient's co-morbidities associated with excess weight. Adjustable gastric banding provides a less invasive, reversible bariatric surgery option. The SAGB has been commercially available outside the United States for this indication since 1996. Commercial availability has led to extensive literature supporting the safety and effectiveness of the SAGB. Given the available literature, a prospective, single arm, multicenter, study in a heterogeneous population of morbidly obese subjects in the U.S. is being conducted.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comprehend, follow and give signed informed consent;
  • 18 to 60 years of age (inclusive);
  • Five year history of morbid obesity;
  • Body Mass Index (BMI) >40 kg/m2 and <55 kg/m2, or BMI >35 kg/m2 and <40 kg/m2 with one or more significant medical conditions related to obesity (co-morbid conditions of type 2 diabetes, hyperlipidemia, obstructive sleep apnea, hypertension, metabolic syndrome, or osteoarthritis of the hip or knee) for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss.
  • 100 lbs. overweight or 1.5 times ideal weight;
  • Documented failure of conservative, non-surgical means of weight reduction within one year prior to the Screening Visit, including failure of supervised diet, exercise and or behavior modification programs, and pharmacologic therapy;
  • Willing to commit to significant lifestyle changes that include diet, eating, and exercise habits for the duration of the clinical trial;
  • Able to commit to long-term follow-up, including band adjustment visits:
  • Living within the contiguous U.S. and is within a 100 mile radius of the study center;
  • Absence of significant psychopathology 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 the follow-up period following SAGB placement; and
  • Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery).

Exclusion Criteria:

  • Women of childbearing potential who are not practicing an effective method of birth control or who are pregnant or lactating;
  • Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
  • Documented history of drug and/or alcohol abuse within two years of the Screening Visit;
  • History of impaired mental status including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations;
  • Presence of any of the following medical conditions;

    • Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease that have been active within the past 10 years;
    • Congenital or acquired anomalies of the GI tract, including atresias or stenosis,
    • Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
    • Uncontrolled hypertension;
    • Portal Hypertension;
    • Uncontrolled Diabetes Mellitus;
    • Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or esophageal varices;
    • Cirrhosis;
    • Congenital or acquired intestinal telangiectasia;
    • Esophageal or gastric disorders including severe preoperative reflux, dysmotility, or Barrett's Esophagus;
    • Presence of hiatal hernia;
    • Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
    • Chronic pancreatitis;
    • Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
    • Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
  • History or presence of pre-existing autoimmune connective tissue disease, i.e., systemic lupus erythematosus or scleroderma;
  • Presence of terminal illness with life expectancy <5 years;
  • Use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation;
  • Acute or chronic infection (localized or systemic);
  • Known or suspected allergy to silicone or other materials contained in the Swedish Adjustable Gastric Band;
  • History of intolerance to implanted devices;
  • Not ambulatory; and
  • Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166205

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Scripps Clinic Medical Group
San Diego, California, United States, 92130
United States, Florida
US Bariatrics
Ft. Lauderdale, Florida, United States, 33308
Advanced Surgical Institute at Mercy Hospital
Miami, Florida, United States, 33133
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Hamilton Medical Center - Weight Management
Dalton, Georgia, United States, 30720
United States, Louisiana
Weight Management Center
New Orleans, Louisiana, United States, 70115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
CAREMAX Surgical, P.C.
East Patchogue, New York, United States, 11772
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
United States, Texas
Surgical Consultants of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Edward Phillips, MD Cedars Sinai
  More Information

No publications provided

Responsible Party: Sheryl Helsinger, Director, Clinical Operations
ClinicalTrials.gov Identifier: NCT00166205     History of Changes
Other Study ID Numbers: CI-02-0006
Study First Received: September 9, 2005
Results First Received: October 21, 2008
Last Updated: January 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
Obesity, Morbid
Obesity
Body Weight

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014