Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

3 août 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

276

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Gastric Band
Single-arm study, all subjects banded.
Dispositif: Swedish Adjustable Gastric Band
Long term implantable device.
Autres noms:
  • Realize Band

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Délai: 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
Délai: 3 Years Post Operative
Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
3 Years Post Operative

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in Excess Body Weight (EBW)
Délai: 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)
Délai: 3 years
Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
3 years
Change in Absolute Weight
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 3 year
Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
3 year
Changes in Low Density Lipoproteins (LDL)
Délai: 3 years
Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
3 years
Changes in Total Cholesterol
Délai: 3 years
Changes in Total Cholesterol, at three-years post-operative minus baseline.
3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ethicon Endo-Surgery

Les enquêteurs

  • Chercheur principal: Edward Phillips, MD, Cedars Sinai

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2003

Achèvement de l'étude (Réel)

1 décembre 2006

Dates d'inscription aux études

Première soumission

9 septembre 2005

Première soumission répondant aux critères de contrôle qualité

9 septembre 2005

Première publication (Estimation)

14 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 septembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2015

Dernière vérification

1 août 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CI-02-0006

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner