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

3 de agosto de 2015 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

276

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Gastric Band
Single-arm study, all subjects banded.
Dispositivo: Swedish Adjustable Gastric Band
Long term implantable device.
Outros nomes:
  • Realize Band

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Prazo: 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
Prazo: 3 Years Post Operative
Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
3 Years Post Operative

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in Excess Body Weight (EBW)
Prazo: 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)
Prazo: 3 years
Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
3 years
Change in Absolute Weight
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 3 year
Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
3 year
Changes in Low Density Lipoproteins (LDL)
Prazo: 3 years
Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
3 years
Changes in Total Cholesterol
Prazo: 3 years
Changes in Total Cholesterol, at three-years post-operative minus baseline.
3 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ethicon Endo-Surgery

Investigadores

  • Investigador principal: Edward Phillips, MD, Cedars Sinai

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de junho de 2003

Conclusão do estudo (Real)

1 de dezembro de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

9 de setembro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de setembro de 2005

Primeira postagem (Estimativa)

14 de setembro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de setembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2015

Última verificação

1 de agosto de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CI-02-0006

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