The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)

NCT ID: NCT01084915

Last Updated: 2014-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement.

This is the first retrospective clinical study of a large study population of \>800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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SAGB VC group

Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* SAGB band placed from 2004-2008

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Homan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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F.J. Berends, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital The Netherlands

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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680-070110-Aarts

Identifier Type: -

Identifier Source: org_study_id

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