NCT00953173

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 Health

93
On Track

Trial Health Score

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

Enrollment
671

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
6 countries

6 active sites

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

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 9, 2018

Completed
Last Updated

March 8, 2018

Status Verified

February 1, 2018

Enrollment Period

6.6 years

First QC Date

August 5, 2009

Results QC Date

August 7, 2017

Last Update Submit

February 8, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • %TBWL

    Percent of total body weight change.

    5 years

Study Arms (1)

LapBand

Patients who have already consented to 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

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.

Also known as: LAP-BAND AP®
LapBand

Eligibility Criteria

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

Patients that have already made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Everett, Washington, United States

Location

Unknown Facility

Adelaide, South Australia, Australia

Location

Unknown Facility

Jette, Belgium

Location

Unknown Facility

Mississauga, Ontario, Canada

Location

Unknown Facility

Naples, Italy

Location

Unknown Facility

Birmingham, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 29265773DERIVED

  • 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.

    PMID: 26154653DERIVED

  • 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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Director of Clinical Affairs
Organization
Apollo Endosurgery Inc
jose.naveira@apolloendo.com
512-279-5157

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

March 8, 2018

Results First Posted

February 9, 2018

Record last verified: 2018-02

Locations

CA(1)US(1)IT(1)BE(1)GB(1)AU(1)