ObesityNCT02356614
A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
An observational study of Obesity and Overweight, run by Apollo Endosurgery, Inc. at 11 sites in United States.
Trial summary
This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- How many people
- 325 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2015to 8 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Obese adult patients with a BMI ≥ 30 kg/m2 and < 40 kg/m2 with one or more comorbid conditions that have had a LAP-BAND® System implanted.
Who may be able to join
- LAP-BAND® System placed in a facility in the United States
- BMI ≥ 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement
- Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
- Aged 18 or older
Who cannot join
- Prior bariatric surgery.
- Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
- Vulnerable patients or those unable to exercise free informed consent.
- Inability to complete the questionnaires.
- Patients who are addicted to alcohol and/or drugs.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Illinois Bariatric Center
Champaign, Illinois, 61820
Bariatric Institute of Greater Chicago
Chicago, Illinois, 60522
Center for Metabolic & Bariatric Surgery
Cincinnati, Ohio, 45241
Utah Lap Band and General Surgery
Draper, Utah, 84020
Surgical Associates
Fountain Valley, California, 92708
Louisville Surgical Associates
Louisville, Kentucky, 40215
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
New York University
New York, New York, 10016
OSF Saint Anthony Medical Center
Rockford, Illinois, 60522-0084
Advanced Weight Loss Surgery
Rockville, Maryland, 20850
St. Alexius New Start
St Louis, Missouri, 63118
About this study
This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation.
The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
Read the detailed description
FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.
The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.
- Conditions
- Obesity, Overweight
- Keywords
- Lap Band
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Explants
The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.
Measured: 5 Years
Secondary outcomes (3)
Response to the LAP-BAND
Secondary objectives include assessment of patients who respond to the LAP BAND® System at 5 years, where response is defined as achieving at least 7%Total Body Loss (TBL), assessment of prevalence of diabetes at 5 years, and assessment of changes in obesity-related comorbid conditions at 5 years.
Measured: 5 Years
Diabetes
Assessment of prevalence of diabetes at 5 years
Measured: 5 Year
Obesity related Comorbidity
Assessment of changes in obesity-related comorbid conditions at Year 5
Measured: 5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion8 Mar 2018
- Study completion8 Mar 2018
Why it stopped: Terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollo Endosurgery, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose L Naveira, Study director, Apollo Endosurgery, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356614
- Sponsor's protocol ID
- Apollo-001
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2015
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
- ClinicalTrials.gov ID
- NCT02356614
- Acronym / sponsor ID
- Apollo-001
- Conditions
- Obesity, Overweight
- Keywords
- Lap Band
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation.
The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
Detailed description
FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.
The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese adult patients with a BMI ≥ 30 kg/m2 and < 40 kg/m2 with one or more comorbid conditions that have had a LAP-BAND® System implanted.
Key inclusion criteria (4 listed)
- LAP-BAND® System placed in a facility in the United States
- BMI ≥ 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement
- Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
- Aged 18 or older
Key exclusion criteria (5 listed)
- Prior bariatric surgery.
- Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
- Vulnerable patients or those unable to exercise free informed consent.
- Inability to complete the questionnaires.
- Patients who are addicted to alcohol and/or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Explants
Time frame: 5 Years
The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.
3 secondary outcomes
Response to the LAP-BAND
Time frame: 5 Years
Diabetes
Time frame: 5 Year
Obesity related Comorbidity
Time frame: 5 Year
Results and safety
The study was stopped early (reason given: Terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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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.
Jose L Naveira study director
Apollo Endosurgery, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Apollo Endosurgery, Inc. at 11 sites in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
The study was stopped early (reason given: Terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.). Results are not available in the source record.
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?
Percentage of Explants (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.