GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

AgNovos Healthcare, LLC44 enrolled

Overview

The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoporosis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022. * Subject has willingness to participate in the study. * Subject can give written informed consent to allow for data collection. Exclusion Criteria: * The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.

Locations (1)

Vitaz

Sint-Niklaas, Belgium

Outcomes

Primary Outcomes

Subject satisfaction

Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.

Time frame: Through study completion, an average of 1.1 years

Subject Safety

Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.

Time frame: During the procedure

Subject Safety

Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.

Time frame: Through study completion, an average of 1.1 years

Data from ClinicalTrials.gov

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