Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00953173




Registration number
NCT00953173
Ethics application status
Date submitted
5/08/2009
Date registered
6/08/2009
Date last updated
8/03/2018

Titles & IDs
Public title
HERO Study: Helping Evaluate Reduction in Obesity
Scientific title
Secondary ID [1] 0 0
HERO Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - LAP-BAND AP® Adjustable Gastric Banding System

LapBand - Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System


Treatment: Devices: LAP-BAND AP® Adjustable Gastric Banding System
The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
%TBWL
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
* Patient and investigator have made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
* Male or female aged = 18 years.
* BMI = 40 or a BMI = 35 with one or more severe co-morbid conditions, or those who are 45.5 Kg / 100 lbs or more over their estimated ideal weight.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior bariatric surgery.
* Type I diabetes patients.
* Participating in another ongoing clinical study with concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
671
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Washington
Country [2] 0 0
Belgium
State/province [2] 0 0
Jette
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Italy
State/province [4] 0 0
Naples
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Apollo Endosurgery, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A prospective, international, multi-center study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND AP® Adjustable Gastric Banding System.
Trial website
https://clinicaltrials.gov/study/NCT00953173
Trial related presentations / publications
Dixon JB, Eaton LL, Curry T, Lee PC. Health Outcomes and Explant Rates After Laparoscopic Adjustable Gastric Banding: A Phase 4, Multicenter Study over 5 Years. Obesity (Silver Spring). 2018 Jan;26(1):45-52. doi: 10.1002/oby.22050.
Lao WL, Malone DC, Armstrong EP, Voellinger D, Somers S, Jin J, Dreyer N, Globe D. Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis. Curr Med Res Opin. 2015 Aug;31(8):1451-60. doi: 10.1185/03007995.2015.1059802. Epub 2015 Jul 25.
Ponce J, Taheri S, Lusco V, Cornell C, Ng-Mak DS, Shi R, Okerson T. Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks. Curr Med Res Opin. 2014 May;30(5):841-8. doi: 10.1185/03007995.2013.874992. Epub 2014 Jan 16.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00953173