AzTrials
AzTrials

Obesity, MorbidPhase 3NCT00166205

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

A Phase 3 study testing Swedish Adjustable Gastric Band in people with Obesity, Morbid, run by Ethicon Endo-Surgery at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid
What is being tested?
Swedish Adjustable Gastric Band
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
12 sitesUnited States
Study dates
Jun 2003to Dec 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
Show all 12Show fewer
  • 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).

Who cannot join

  • 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;
Show all 28Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Hamilton Medical Center - Weight Management

    Dalton, Georgia, 30720

  • CAREMAX Surgical, P.C.

    East Patchogue, New York, 11772

  • US Bariatrics

    Fort Lauderdale, Florida, 33308

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Advanced Surgical Institute at Mercy Hospital

    Miami, Florida, 33133

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Weight Management Center

    New Orleans, Louisiana, 70115

  • St. Luke's-Roosevelt Hospital Center

    New York, New York, 10025

  • Surgical Consultants of San Antonio

    San Antonio, Texas, 78229

  • Scripps Clinic Medical Group

    San Diego, California, 92130

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Obesity, Morbid
Being tested
Swedish Adjustable Gastric Band
Keywords
Obesity, Morbid, Obesity, Body Weight
Medical subject headings
Obesity, Morbid, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swedish Adjustable Gastric BandDevice

    Also called Realize Band

    Long term implantable device.

Study groups in NCT00166205
Study groupRoleWhat they receive
Gastric BandExperimentalSingle-arm study, all subjects banded.
Receives: Device: Swedish Adjustable Gastric Band

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. Percent Excess Weight Loss

    Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.

    Measured: 3 Years Post Operative

Secondary outcomes (9)

  1. 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.

    Measured: 3 years

  2. Changes in Body Mass Index (BMI)

    Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. Changes in Glycosylated Hemoglobin (HbA1c)

    Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.

    Measured: 3 years

  6. 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).

    Measured: 3 Years

  7. Changes in High Density Lipoproteins (HDL)

    Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.

    Measured: 3 year

  8. Changes in Low Density Lipoproteins (LDL)

    Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.

    Measured: 3 years

  9. Changes in Total Cholesterol

    Changes in Total Cholesterol, at three-years post-operative minus baseline.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00166205
Sponsor's protocol ID
CI-02-0006
Status last verified
Aug 2015
First submitted
9 Sep 2005
Last updated
1 Sep 2015
Data monitoring committee
No

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.

    PubMed 18501317

  • 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.

    PubMed 19342314

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Swedish Adjustable Gastric Band in people with Obesity, Morbid, run by Ethicon Endo-Surgery at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00166205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in