NCT00501085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

6.2 years

First QC Date

July 11, 2007

Results QC Date

January 8, 2015

Last Update Submit

January 15, 2015

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 5 Years

Secondary Outcomes (4)

  • Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation

    Baseline to 5 years

  • Subject Reported Satiety

    Baseline to 5 Years

  • Subject Reported Quality of Life

    Baseline to 5 Years

  • Subject Reported Sleepiness (Epworth Sleepiness Scale)

    Baseline to 5 years

Study Arms (1)

LAP-BAND

Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.

Device: LAP-BAND AP Adjustable Gastric Banding System

Interventions

LAP-BAND AP Adjustable Gastric Banding SystemDEVICE

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

LAP-BAND

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Apollo Endosurgery

Austin, Texas, 78746, United States

Location

Related Publications (3)

  • 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.

    PMID: 24328415DERIVED

  • 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.

    PMID: 24328387DERIVED

  • 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.

    PMID: 22913906DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Laura Eaton, R.N., BSN, CCRN-R
Organization
Apollo Endosurgery, Inc.
laura.eaton@apolloendo.com
949-468-9301

Study Officials

  • Apollo Endosurgery

    Apollo Endosurgery, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 13, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

January 19, 2015

Results First Posted

January 19, 2015

Record last verified: 2015-01

Locations

US(1)