GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

July 28, 2023 updated by: AgNovos Healthcare, LLC

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Sint-Niklaas, Belgium, 9100
        • VITAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients treated with AGN1 LOEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject satisfaction
Time Frame: Through study completion, an average of 1.1 years
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
Subject Safety
Time Frame: During the procedure
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
Subject Safety
Time Frame: Through study completion, an average of 1.1 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AgNovos Healthcare, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

April 3, 2023

Study Completion (Actual)

April 3, 2023

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN-CIP-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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