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

NCT02356614 | Terminated

• 1 other identifier: Apollo-001
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Obesity; Overweight

Keywords

Lap Band

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response to the LAP-BAND

  5 Years

• Diabetes

  5 Year

• Obesity related Comorbidity

  5 Year

Other Outcomes (1)

• Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events

  10 Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese adult patients with a BMI ≥ 30 kg/m2 and \< 40 kg/m2 with one or more comorbid conditions that have had a LAP-BAND® System implanted.

You may qualify if:

• LAP-BAND® System placed in a facility in the United States
• BMI ≥ 30 kg/m2 and \< 40 kg/m2 prior to LAP-BAND® placement
• Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
• Aged 18 or older

You may not qualify if:

• Prior bariatric surgery.
• 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.
• Vulnerable patients or those unable to exercise free informed consent.
• Inability to complete the questionnaires.
• Patients who are addicted to alcohol and/or drugs.

Sponsors & Collaborators

• Apollo Endosurgery, Inc.: lead

Study Sites (11)

Surgical Associates

Fountain Valley, California, 92708, United States

Location

Illinois Bariatric Center

Champaign, Illinois, 61820, United States

Location

Bariatric Institute of Greater Chicago

Chicago, Illinois, 60522, United States

Location

OSF Saint Anthony Medical Center

Rockford, Illinois, 60522-0084, United States

Location

Louisville Surgical Associates

Louisville, Kentucky, 40215, United States

Location

Surgical Specialists of Louisiana

Metairie, Louisiana, 70001, United States

Location

Advanced Weight Loss Surgery

Rockville, Maryland, 20850, United States

Location

St. Alexius New Start

St Louis, Missouri, 63118, United States

Location

New York University

New York, New York, 10016, United States

Location

Center for Metabolic & Bariatric Surgery

Cincinnati, Ohio, 45241, United States

Location

Utah Lap Band and General Surgery

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L Naveira

  Apollo Endosurgery, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: March 1, 2015
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-03

Locations

US (11)