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

3. august 2015 oppdatert av: Ethicon Endo-Surgery

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

276

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gastric Band
Single-arm study, all subjects banded.
Enhet: Swedish Adjustable Gastric Band
Long term implantable device.
Andre navn:
  • Realize Band

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Tidsramme: 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.
3 years
Percent Excess Weight Loss
Tidsramme: 3 Years Post Operative
Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
3 Years Post Operative

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Excess Body Weight (EBW)
Tidsramme: 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.
3 years
Changes in Body Mass Index (BMI)
Tidsramme: 3 years
Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
3 years
Change in Absolute Weight
Tidsramme: 3 years
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
Tidsramme: 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.
3 years
Changes in Glycosylated Hemoglobin (HbA1c)
Tidsramme: 3 years
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
Tidsramme: 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).
3 Years
Changes in High Density Lipoproteins (HDL)
Tidsramme: 3 year
Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
3 year
Changes in Low Density Lipoproteins (LDL)
Tidsramme: 3 years
Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
3 years
Changes in Total Cholesterol
Tidsramme: 3 years
Changes in Total Cholesterol, at three-years post-operative minus baseline.
3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ethicon Endo-Surgery

Etterforskere

  • Hovedetterforsker: Edward Phillips, MD, Cedars Sinai

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2003

Studiet fullført (Faktiske)

1. desember 2006

Datoer for studieregistrering

Først innsendt

9. september 2005

Først innsendt som oppfylte QC-kriteriene

9. september 2005

Først lagt ut (Anslag)

14. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. september 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2015

Sist bekreftet

1. august 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CI-02-0006

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