NCT01078194

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 25, 2010

Status Verified

January 1, 2010

Enrollment Period

3 years

First QC Date

March 1, 2010

Last Update Submit

May 24, 2010

Conditions

Morbid Obesity

Keywords

Weight regainWeight loss failureGastric bypass

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Excessive weight loss

    2 years

Study Arms (1)

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

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

Interventions

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

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

Also known as: A.M.I. Soft Gastric Band
Weight regain / weight loss failure

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass

You may qualify if:

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

You may not qualify if:

  • Formerly leak at the gastrojejunostomy
  • Formerly open abdominal surgery
  • Anastomotic ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Surgery

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerhard Prager, M.D.

    Medical University of Vienna, Department of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Prager, M.D.

CONTACT

+43-1-40400gerhard.prager@meduniwien.ac.at

Felix B Langer, M.D.

CONTACT

+43-1-40400felix.langer@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 25, 2010

Record last verified: 2010-01

Locations

AU(1)