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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01183975
Other study ID # 05-FR-004
Secondary ID
Status Completed
Phase N/A
First received August 17, 2010
Last updated August 6, 2014
Start date September 2007
Est. completion date April 2012

Study information

Verified date August 2014
Source Ethicon Endo-Surgery (Europe) GmbH
Contact n/a
Is FDA regulated No
Health authority France: Haute Autorité de Santé Transparency Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.

No comparator group. No randomization or blinding techniques


Description:

Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

The study is originated in collaboration with HAS in France and has a target of 500 patients treated with gastric banding because of morbid obesity.


Recruitment information / eligibility

Status Completed
Enrollment 517
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- morbidly obese patients (BMI>35 with comorbidities or BMI>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice

Exclusion Criteria:

- lower BMI, contraindications based on local clinical assessment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Polyclinique Rillieux Rillieux-La-Pape

Sponsors (1)

Lead Sponsor Collaborator
Ethicon Endo-Surgery (Europe) GmbH

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean BMI Change Mean change in BMI for valid subjects 3 years follow-up No
Primary Mean Excess Weight Change Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51). 3 years follow up No
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