EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP

Status Recruiting

Clinical Trial Summary

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Osteoporosis

Clinical Trial Details

NCT number	NCT04511364
Study type	Interventional
Source	AgNovos Healthcare, LLC
Contact	Adam Lowe
Phone	240753-6500
Email	alowe@agnovos.com
Status	Recruiting
Phase	N/A
Start date	August 28, 2020
Completion date	December 2025

View Details

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