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

NCT02356614 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2018-06-27

No results posted yet for this study

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

Sponsors & Collaborators

  • Apollo Endosurgery, Inc.

    lead INDUSTRY

Principal Investigators

  • Jose L Naveira · Apollo Endosurgery, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-03-08
Completion
2018-03-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356614 on ClinicalTrials.gov