The Results and Outcomes of the Modified Swedish Adjustab... | NCT01084915

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

NCT01084915

Sponsor

Rijnstate Hospital

Status

Completed

Last Update Posted

Mar 6, 2014Estimated

Enrollment

840Actual

Phase

Not provided

Conditions

Weight Loss

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Mar 10, 2010

First Submission Date that Met QC Criteria

Mar 10, 2010

First Posted Date

Mar 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2014

Last Update Posted Date

Mar 6, 2014Estimated

Name	Class
Ethicon, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

840Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAGB VC group		Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss	The amount of weight loss over time is researched	2 months

Secondary Outcomes

Measure	Description	Time Frame
Bariatric Analysis and Reporting Outcome System (BAROS) score	A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized	2 months
Operating time	Operating time is inventorized

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SAGB band placed from 2004-2008

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who received a SAGB-VC band from 2004-2008

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
F.J. Berends, MD, PhD	Rijnstate Hospital The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate Hospital		Arnhem	Gelderland	6800 TA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided