- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00580502
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2 (LBMI)
A Prospective Study to Evaluate the Safety and Efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) Operations for Patients With BMI Between 30-40 kg/m2 With Co-morbidities
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA
STUDY OBJECTIVES
- To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
- To determine long-term effects on patients' co-morbidities
STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation
DESIGN: Prospective single center study
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Be at least 18 and equal to or less than 60 years of age.
- BMI of at least 30 and maximum BMI of 40 with co-morbidities
- Willingness to comply with dietary restrictions required by the protocol
- History of obesity for at least 5 years
- History of at least 6 months of documented failures with traditional non-surgical weight loss methods
- Willingness to follow protocol requirements
- If female with childbearing potential, using an appropriate form of contraception
Exclusion Criteria:
- Age less than 18, age greater than 60
- Pregnancy
- History of major depressive disorder or psychosis
- Previous bariatric surgery or previous gastric surgery
- Presence of achalasia
- Presence of portal hypertension, cirrhosis, and/or varices
- Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
- Patients with autoimmune connective tissue disorders
- Patients with acute abdominal infections
- Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: LAGB for low BMI patients
the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
|
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
Tidsramme: 5 years
|
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
|
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Tidsramme: 5 years
|
Change in level of LDL from baseline at 5 years
|
5 years
|
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Tidsramme: 5 years
|
Change in level of Triglycerides from baseline at 5 years
|
5 years
|
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
Tidsramme: 5 years
|
Change in level of HbA1c from baseline at 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine Ren-Fielding, M.D., NYUSOM
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H # 10686
- 10686 (Anden identifikator: NYULMC IRB)
- G030190 (Anden identifikator: FDA)
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