HERO Study: Helping Evaluate Reduction in Obesity

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953173
• Other study ID #: HERO Study
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: February 8, 2018
• Start date: December 2009
• Est. completion date: October 2016

Study information

• Verified date: February 2018
• Source: Apollo Endosurgery, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• LAP-BAND AP® Adjustable Gastric Banding System
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Endosurgery, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%TBWL	Percent of total body weight change.	5 years