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

A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Device: Swedish Adjustable Gastric 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.

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric Band; Single-arm study, all subjects banded.	Device: Swedish Adjustable Gastric Band; Long term implantable device.; Other Names: Realize Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)	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.	3 years
Percent Excess Weight Loss	Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.	3 Years Post Operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Excess Body Weight (EBW)	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.	3 years
Changes in Body Mass Index (BMI)	Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.	3 years
Change in Absolute Weight	Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.	3 years
Changes in Quality of Life (QOL) Measures	Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.	3 years
Changes in Glycosylated Hemoglobin (HbA1c)	Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.	3 years
Number of All Adverse Events of Subjects Implanted With the SAGB	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).	3 Years
Changes in High Density Lipoproteins (HDL)	Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.	3 year
Changes in Low Density Lipoproteins (LDL)	Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.	3 years
Changes in Total Cholesterol	Changes in Total Cholesterol, at three-years post-operative minus baseline.	3 years

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Edward Phillips, MD, Cedars Sinai

Publications and helpful links

General Publications

• Phillips E; SAGB Study Group. Design and demography of the United States Swedish Adjustable Gastric Band trial: a 3-year prospective study. Surg Obes Relat Dis. 2008 May-Jun;4(3 Suppl):S63-72. doi: 10.1016/j.soard.2008.04.009.
• Phillips E, Ponce J, Cunneen SA, Bhoyrul S, Gomez E, Ikramuddin S, Jacobs M, Kipnes M, Martin L, Marema RT, Pilcher J, Rosenthal R, Rubenstein R, Teixeira J, Trus T, Zundel N. Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States. Surg Obes Relat Dis. 2009 Sep-Oct;5(5):588-97. doi: 10.1016/j.soard.2008.12.007. Epub 2009 Jan 18.

Helpful Links

• PubMed Abstract 3-yr Results
• PubMed Abstract Design

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Body Weight; Obesity, Morbid
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CI-02-0006