CompletedNot Applicable

GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

Belgium44 participantsStarted 2022-12-15

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

Subject satisfaction

Timeframe: Through study completion, an average of 1.1 years

Subject Safety

Timeframe: During the procedure

Subject Safety

Timeframe: Through study completion, an average of 1.1 years

Trial details

NCT IDNCT05966974

SponsorAgNovos Healthcare, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-03

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