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

November 28, 2022 updated by: AgNovos Healthcare, LLC

Long-term Follow-up in Osteoporotic Women Treated With Local Osteo-Enhancement in Europe

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Sint-Niklaas, Belgium, 9100
        • Recruiting
        • AZ Nikolaas
        • Contact:
          • Koen Bulterys

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
  • Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  • Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

  • Subject was withdrawn from CONFIRM.
  • Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGN1 treated patients
Patients have been treated with the AGN1 LOEP kit in AgNovos study PST-EU-101.1. An X-ray and DXA scan are performed at 24 and 60 months post AGN1 LOEP treatment.
Other: Clinical imaging is performed during the 24 and 60 month follow-up visits
X-ray and DXA scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DXA score at 24 months
Time Frame: 24 months
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DXA score at 60 months
Time Frame: 60 months
Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
60 months
Hip fracture incidence
Time Frame: 60 months
The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.
60 months
Radiologic bone formation
Time Frame: 60 months
Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.
60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: 60 months
The incidence of all serious adverse events during follow-up determined to be at least possibly related to the procedure and/or device through 60 months post-AGN1 LOEP treatment.
60 months

Collaborators and Investigators

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

Sponsor

AgNovos Healthcare, LLC

Investigators

  • Principal Investigator: Jo De Schepper, MD, AZ Nikolaas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 28, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN-CIP-300

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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