Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band

A Post Implantation/Post Market Evaluation of Safety and Quality of Life in Subjects Implanted With the Swedish Adjustable Gastric Band (SAGB) During Protocol CI-02-0006

Patrocinadores

Patrocinador principal: Ethicon Endo-Surgery

Fuente Ethicon Endo-Surgery
Resumen breve

The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.

Descripción detallada

NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205 (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required additional subjects with long-term safety data. These subjects enrolled under protocol CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original intent was to pool the data together from the above two studies to obtain the appropriate sample size for estimation of the re-operation rate at 4 and 5 years post implantation.

Estado general Completed
Fecha de inicio August 2006
Fecha de Terminación January 2015
Fecha de finalización primaria January 2015
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant. 5 years
Resultado secundario
Medida Periodo de tiempo
Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant. 5 years
Percent Change in Excess Body Weight at 5 Years Post-implant 5 years
Change in SF-36 Health Survey Physical Component at 5 Years Post Implant 5 years
Change in SF-36 Health Survey Mental Component at 5 Years Post Implant 5 years
Inscripción 303
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: REALIZE™ Swedish Adjustable Gastric Band

Descripción: Laparoscopic placement of the Swedish Adjustable Gastric Band

Etiqueta de grupo de brazo: REALIZE™ Swedish Adjustable Gastric Band

Otro nombre: REALIZE Band

Elegibilidad

Criterios:

CI-06-0001 Inclusion Criteria:

Subjects eligible to participate in this study must fulfill all of the following criteria:

1. Able to comprehend, follow and give signed informed consent;

2. Consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity";

3. Currently have an SAGB implant in place;

4. Able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits; and

5. Living within the contiguous U.S.

CI-07-0006 Inclusion Criteria:

Subjects eligible to participate in this study must fulfill all of the following criteria:

1. Able to comprehend, follow and give informed consent;

2. 18 to 60 years of age (inclusive);

3. Body Mass Index (BMI) of > 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and < 40 kg/m2 with one or more co-morbid conditions.

4. Candidate for surgical weight loss intervention in accordance with the Instructions For Use (i.e., meets acceptable health criteria for major surgery).

CI-06-0001 Exclusion Criteria:

Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study:

a. Consented to, and participated in EES Protocol CI-02-0006 titled "A aSingle-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"; and have had the SAGB explanted.

CI-07-0006 Exclusion Criteria:

1. Women who are currently pregnant.

2. Previous malabsorptive or restrictive procedures performed for the treatment of morbid obesity.

3. Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit (1a).

4. Presence of any of the following medical conditions;

1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;

2. Severe cardiopulmonary disease or other serious organic disease;

3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;

4. Portal hypertension;

5. Anomalies of the gastrointestinal tract such as atresia or stenosis;

6. Cirrhosis of the liver;

7. Chronic pancreatitis;

8. Patients on chronic, long-term steroid treatment or steroids within 15 days of surgery;

9. Unable or unwilling to comply with dietary restrictions required by this procedure;

10. Known allergy to materials contained within the band or its injection port (silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and cobalt chromium)

5. Presence of terminal illness with life expectancy of £ 5 years.

6. Inability to refrain from use of anticoagulants or aspirin within 15 days prior to surgery.

7. Acute or chronic infection (localized or systemic).

8. Participation in another clinical trial within 8 weeks of the Screening Visit (1a) and for the duration of this trial.

9. Any medical condition or finding for which the Investigator utilizes their medical discretion to determine the subject should be excluded due to inability to understand or follow study procedures.

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Edward Phillips, MD Principal Investigator Cedars Sinai
Ubicación
Instalaciones:
Surgical Associates of La Jolla Medical Group, Inc. | La Jolla, California, 92037, United States
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States
Advanced Surgical Institute at Mercy Hospital | Miami, Florida, 33133, United States
Robert T. Marema, MD | St. Augustine, Florida, 32086, United States
Cleveland Clinic Florida | Weston, Florida, 33331, United States
Hamilton Medical Center - Weight Management | Dalton, Georgia, 30722, United States
St. Luke's Roosevelt Hospital Center | New York, New York, 10025, United States
dgd Research, Inc. | San Antonio, Texas, 78229, United States
Ubicacion Paises

United States

Fecha de verificación

February 2016

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: REALIZE™ Swedish Adjustable Gastric Band

Tipo: Other

Descripción: All subjects have the REALIZE™ Swedish Adjustable Gastric Band. Single arm - no comparator.

Acrónimo SAGB-PM
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov