ObesityNCT00953173
HERO Study: Helping Evaluate Reduction in Obesity
An observational study of Obesity, run by Apollo Endosurgery, Inc. at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- LAP-BAND AP® Adjustable Gastric Banding System
- Type of treatment
- Medical device
- How many people
- 671 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Dec 2009to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have already made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
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.
- Conditions
- Obesity
- Being tested
- LAP-BAND AP® Adjustable Gastric Banding System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAP-BAND AP® Adjustable Gastric Banding SystemDevice
Also called LAP-BAND AP®
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.
| Study group | Role | What they receive |
|---|---|---|
| LapBand | Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System Receives: Device: LAP-BAND AP® Adjustable Gastric Banding System |
What is being measured
The primary outcome is the main question the study is designed to answer.
%TBWL
Percent of total body weight change.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Endosurgery, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953173
- Sponsor's protocol ID
- HERO Study
- Status last verified
- Feb 2018
- First submitted
- 5 Aug 2009
- Last updated
- 8 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 29265773Lao 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.
PubMed 26154653Ponce 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.
PubMed 24328415
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HERO Study: Helping Evaluate Reduction in Obesity
- ClinicalTrials.gov ID
- NCT00953173
- Acronym / sponsor ID
- HERO Study
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 9 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LapBand | – | Device: LAP-BAND AP® Adjustable Gastric Banding SystemPatients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have already made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAP-BAND AP® Adjustable Gastric Banding SystemAlso: LAP-BAND AP®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. | Device | LapBand |
Primary outcome
%TBWL
Time frame: 5 years
Percent of total body weight change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29265773Dixon 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.
- Derived from this study: PubMed 26154653Lao 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.
- Derived from this study: PubMed 24328415Ponce 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Apollo Endosurgery, Inc. at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Belgium, Canada, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%TBWL (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953173, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.