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
1 other identifier
interventional
276
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2003
Typical duration for phase_3
12 active sites
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
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedResults Posted
Study results publicly available
December 11, 2008
CompletedSeptember 1, 2015
August 1, 2015
September 9, 2005
October 21, 2008
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Changes in Excess Body Weight (EBW)
3 years
Changes in Body Mass Index (BMI)
3 years
Change in Absolute Weight
3 years
Changes in Quality of Life (QOL) Measures
3 years
Changes in Glycosylated Hemoglobin (HbA1c)
3 years
- +4 more secondary outcomes
Study Arms (1)
Gastric Band
EXPERIMENTALSingle-arm study, all subjects banded.
Interventions
Long term implantable device.
Eligibility Criteria
You may qualify if:
- Able to comprehend, follow and give signed informed consent;
- 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.
- 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).
You may not qualify if:
- 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;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Scripps Clinic Medical Group
San Diego, California, 92130, United States
US Bariatrics
Fort Lauderdale, Florida, 33308, United States
Advanced Surgical Institute at Mercy Hospital
Miami, Florida, 33133, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Hamilton Medical Center - Weight Management
Dalton, Georgia, 30720, United States
Weight Management Center
New Orleans, Louisiana, 70115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
CAREMAX Surgical, P.C.
East Patchogue, New York, 11772, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025, United States
Surgical Consultants of San Antonio
San Antonio, Texas, 78229, United States
Related Publications (2)
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.
PMID: 18501317BACKGROUNDPhillips 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.
PMID: 19342314RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sheryl Helsinger, Director
- Organization
- Worldwide Clinical Operations
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Phillips, MD
Cedars Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
June 1, 2003
Study Completion
December 1, 2006
Last Updated
September 1, 2015
Results First Posted
December 11, 2008
Record last verified: 2015-08