Obesity, MorbidNCT00501085

LAP-BAND AP Early Experience Trial (APEX)

An observational study of Obesity, Morbid, run by Apollo Endosurgery, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Morbid
What is being tested?: LAP-BAND AP Adjustable Gastric Banding System
Type of treatment: Medical device
How many people: 521 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Nov 2013
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: Community sample

Who may be able to join

Patient is scheduled to receive the LAP-BAND AP System
Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.

Who cannot join

Per the LAP-BAND AP System Directions For Use (DFU)

Trial locations and contacts

1 site in 1 country.

United States1 site

Apollo Endosurgery
Austin, Texas, 78746

Other trials in United States

About this study

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Read the detailed description

The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.

Conditions: Obesity, Morbid
Being tested: LAP-BAND AP Adjustable Gastric Banding System
Medical subject headings: Obesity, Morbid

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
Reduction of food intake due to creation of smaller stomach pouch.

Study groups in NCT00501085
Study group	Role	What they receive
LAP-BAND		Patients who 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.

Change in Percent Excess Weight
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
Measured: Baseline to 5 Years

Secondary outcomes (4)

Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
Measured: Baseline to 5 years
Subject Reported Satiety
Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
Measured: Baseline to 5 Years
Subject Reported Quality of Life
Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
Measured: Baseline to 5 Years
Subject Reported Sleepiness (Epworth Sleepiness Scale)
The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).
Measured: Baseline to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Nov 2013

First posted13 Jul 2007 (estimated)
Study startJun 2007
Primary completionAug 2013
Study completionNov 2013

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 Obesity, MorbidStudies 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: Case only
Time perspective: Prospective
Enrolment: 521 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00501085
Sponsor's protocol ID: MedAff-LBAP201
Status last verified: Jan 2015
First submitted: 11 Jul 2007
Last updated: 19 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 24328415
Fusco M, James S, Cornell C, Okerson T. Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study. Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17.
PubMed 24328387
Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561.
PubMed 22913906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LAP-BAND AP Early Experience Trial (APEX)
ClinicalTrials.gov ID: NCT00501085
Acronym / sponsor ID: MedAff-LBAP201
Conditions: Obesity, Morbid
Study type: Observational
Recruitment status: Completed
Enrolment: 521 participants (actual)
Lead sponsor: Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Aug 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 13 Jul 2007 (estimated)
Results: Posted 19 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
LAP-BAND	–	Device: LAP-BAND AP Adjustable Gastric Banding SystemPatients who 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: Community sample

Key inclusion criteria (2 listed)

Patient is scheduled to receive the LAP-BAND AP System
Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.

Key exclusion criteria (1 listed)

Per the LAP-BAND AP System Directions For Use (DFU)

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 SystemReduction of food intake due to creation of smaller stomach pouch.	Device	LAP-BAND

Primary outcome

Change in Percent Excess Weight
Time frame: Baseline to 5 Years
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.

4 secondary outcomes

Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
Time frame: Baseline to 5 years
Subject Reported Satiety
Time frame: Baseline to 5 Years
Subject Reported Quality of Life
Time frame: Baseline to 5 Years
Subject Reported Sleepiness (Epworth Sleepiness Scale)
Time frame: Baseline to 5 years

Results and safety

Results posted to the registry on 19 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAP-BAND	515	83

Primary outcome: Change in Percent Excess Weight

Time frame: Baseline to 5 Years. Mean (Standard Deviation). Unit: percentage of excess weight lost

Measure	LAP-BAND n = 515
%EWL from baseline 48 Weeks Post-Surgery (n=402)	-45.7 (21.26)
%EWL from baseline 24 Months Post-Surgery (n=304)	-50.8 (26.70)
%EWL from baseline 36 Months Post-Surgery (n=226)	-47.7 (30.21)
%EWL from baseline 48 Months Post-Surgery (n=156)	-46.5 (27.23)
%EWL from baseline 60 Months Post-Surgery (n=84)	-45.9 (26.80)

Population analysed: The analysis population is defined as all subjects treated with the LAP-BAND System.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAP-BAND	38 of 515 (7.4%)	158 of 515 (30.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 24328387Fusco M, James S, Cornell C, Okerson T. Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study. Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17.
Derived from this study: PubMed 22913906Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561.

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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.

Apollo Endosurgery study director

Apollo Endosurgery, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid, run by Apollo Endosurgery, Inc. at 1 site 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 2 inclusion and 1 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 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 19 Jan 2015). 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?

Change in Percent Excess Weight (time frame: Baseline to 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 NCT00501085, 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 19 Jan 2015.