NCT02123992

Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse

A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.

Detailed description

The Harmony 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Elevate Apical and Posterior
PROCEDURE	Native Tissue Repair for pelvic organ prolapse

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2014-04-28
• Last updated: 2016-09-07

Locations

23 sites across 1 country: United States