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

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ClinicalTrials.gov Identifier: NCT00166205
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : December 11, 2008
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:
Ethicon Endo-Surgery

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE October 21, 2008
Results First Posted Date  ICMJE December 11, 2008
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) [ Time Frame: 3 years ]
    Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.
  • Percent Excess Weight Loss [ Time Frame: 3 Years Post Operative ]
    Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • *Effectiveness of the SAGB post-operatively (for the follow-up period)
  • *Rate of device-related adverse events and SAGB malfunctions in subjects implanted with the SAGB throughout the post-operative follow-up period.
Change History Complete list of historical versions of study NCT00166205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • Changes in Excess Body Weight (EBW) [ Time Frame: 3 years ]
    Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.
  • Changes in Body Mass Index (BMI) [ Time Frame: 3 years ]
    Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
  • Change in Absolute Weight [ Time Frame: 3 years ]
    Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.
  • Changes in Quality of Life (QOL) Measures [ Time Frame: 3 years ]
    Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.
  • Changes in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 3 years ]
    Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.
  • Number of All Adverse Events of Subjects Implanted With the SAGB [ Time Frame: 3 Years ]
    The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).
  • Changes in High Density Lipoproteins (HDL) [ Time Frame: 3 year ]
    Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
  • Changes in Low Density Lipoproteins (LDL) [ Time Frame: 3 years ]
    Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
  • Changes in Total Cholesterol [ Time Frame: 3 years ]
    Changes in Total Cholesterol, at three-years post-operative minus baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • *Changes in excess body weight throughout post-operative follow-up period
  • *Change in body mass index (BMI) throughout the post-operative follow-up period
  • *Absolute weight loss and percent change in absolute weight throughout the post-operative follow-up period
  • *Change in Quality of Life measures throughout the post-operative follow-up period
  • *Changes in specific laboratory test values throughout the post-operative follow-up period
  • *Rate of all adverse events in subjects implanted with the SAGB throughout the post-operative follow-up period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
Official Title  ICMJE A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity, Morbid
Intervention  ICMJE Device: Swedish Adjustable Gastric Band
Long term implantable device.
Other Name: Realize Band
Study Arms  ICMJE Experimental: Gastric Band
Single-arm study, all subjects banded.
Intervention: Device: Swedish Adjustable Gastric Band
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2005)
276
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00166205
Other Study ID Numbers  ICMJE CI-02-0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheryl Helsinger, Director, Clinical Operations
Study Sponsor  ICMJE Ethicon Endo-Surgery
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Phillips, MD Cedars Sinai
PRS Account Ethicon Endo-Surgery
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP