GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

Osteoporosis Clinical Trial

Official title:

Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966974
• Other study ID #: AGN-CIP-302
• Status: Completed
• Start date: December 15, 2022
• Est. completion date: April 3, 2023

Study information

• Verified date: July 2023
• Source: AgNovos Healthcare, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
Belgium	Vitaz	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
AgNovos Healthcare, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1.1 years
Primary	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.	During the procedure
Primary	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.	Through study completion, an average of 1.1 years