Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

NCT ID: NCT01078194

Last Updated: 2010-05-25

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Weight regain / weight loss failure

Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass

Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)

Intervention Type DEVICE

Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding

Interventions

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Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)

Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding

Intervention Type DEVICE

Other Intervention Names

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A.M.I. Soft Gastric Band

Eligibility Criteria

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Inclusion Criteria

* Weight regain of more than 10 kg from nadir
* Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass

Exclusion Criteria

* Formerly leak at the gastrojejunostomy
* Formerly open abdominal surgery
* Anastomotic ulcer
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna / Department of Surgery

Principal Investigators

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Gerhard Prager, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Surgery

Locations

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Medical University of Vienna, Department of Surgery

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gerhard Prager, M.D.

Role: CONTACT

+43-1-40400 ext. 5621

Felix B Langer, M.D.

Role: CONTACT

+43-1-40400 ext. 5621

Facility Contacts

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Gerhard Prager, M-D-

Role: primary

+43-1-40400 ext. 5621

Felix B Langer, M.D.

Role: backup

+43-1-40400 ext. 5621

Other Identifiers

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MUW ADIP STUDY 16

Identifier Type: -

Identifier Source: org_study_id

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