A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

Obesity Clinical Trial

Official title:

A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02356614
• Other study ID #: Apollo-001
• Status: Terminated
• Start date: March 2015
• Est. completion date: March 8, 2018

Study information

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

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 325
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. LAP-BAND® System placed in a facility in the United States

2. BMI = 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement

3. Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement

4. Aged 18 or older

Exclusion Criteria:

1. Prior bariatric surgery.

2. 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.

3. Vulnerable patients or those unable to exercise free informed consent.

4. Inability to complete the questionnaires.

5. Patients who are addicted to alcohol and/or drugs.

Related Conditions & MeSH terms

• Obesity
• Overweight

Locations

Country	Name	City	State
United States	Illinois Bariatric Center	Champaign	Illinois
United States	Bariatric Institute of Greater Chicago	Chicago	Illinois
United States	Center for Metabolic & Bariatric Surgery	Cincinnati	Ohio
United States	Utah Lap Band and General Surgery	Draper	Utah
United States	Surgical Associates	Fountain Valley	California
United States	Louisville Surgical Associates	Louisville	Kentucky
United States	Surgical Specialists of Louisiana	Metairie	Louisiana
United States	New York University	New York	New York
United States	OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Advanced Weight Loss Surgery	Rockville	Maryland
United States	St. Alexius New Start	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events	Percentage of patients experiencing reoperations, esophageal dilatation, esophageal dysmotility, and other device-related and procedure-related adverse events observed over the study assessment period.	10 Years
Primary	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.	5 Years
Secondary	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.	5 Years
Secondary	Diabetes	Assessment of prevalence of diabetes at 5 years	5 Year
Secondary	Obesity related Comorbidity	Assessment of changes in obesity-related comorbid conditions at Year 5	5 Year