Clinical trial NCT00166205: Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity, Morbid
Keywords: Obesity, Morbid
Obesity
Body Weight
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
timeFrame: 3 years
measure: Percent Excess Weight Loss
timeFrame: 3 Years Post Operative
Secondary outcomes:
measure: Changes in Excess Body Weight (EBW)
timeFrame: 3 years
measure: Changes in Body Mass Index (BMI)
timeFrame: 3 years
measure: Change in Absolute Weight
timeFrame: 3 years
measure: Changes in Quality of Life (QOL) Measures
timeFrame: 3 years
measure: Changes in Glycosylated Hemoglobin (HbA1c)
timeFrame: 3 years
measure: Number of All Adverse Events of Subjects Implanted With the SAGB
timeFrame: 3 Years
measure: Changes in High Density Lipoproteins (HDL)
timeFrame: 3 year
measure: Changes in Low Density Lipoproteins (LDL)
timeFrame: 3 years
measure: Changes in Total Cholesterol
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Scripps Clinic Medical Group
state: California
city: Ft. Lauderdale
country: United States
facility: US Bariatrics
state: Florida
city: Miami
country: United States
facility: Advanced Surgical Institute at Mercy Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Dalton
country: United States
facility: Hamilton Medical Center - Weight Management
state: Georgia
city: New Orleans
country: United States
facility: Weight Management Center
state: Louisiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: East Patchogue
country: United States
facility: CAREMAX Surgical, P.C.
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
city: San Antonio
country: United States
facility: Surgical Consultants of San Antonio
state: Texas
Study officials:
affiliation: Cedars Sinai
name: Edward Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.