CONFIRM Europe Safety Study (CONFIRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02916953|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Device: AGN1 Femoral Local Osteo-Enhancement Procedure||Not Applicable|
This research study will be conducted as a post-CE Mark prospective multi-center study within Europe. In total 60 patients will be treated with the OSSURE LOEP kit.
Follow-up visits will be conducted ten (10) and forty-two (42) days after the procedure. In addition, all subjects will have the option to consent for a long term follow-up evaluation at twelve (12) months post-procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Safety of a Local Osteo-Enhancement Procedure (LOEP™) Intended to Increase Bone Strength in the Proximal Femur of Women in Europe With Osteoporosis|
|Actual Study Start Date :||December 17, 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||September 2021|
All subjects who meet the inclusion and exclusion criteria will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) treatment
Device: AGN1 Femoral Local Osteo-Enhancement Procedure
A procedure that is intended to increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. Local treatment of the proximal femur with AGN1 is intended to be adjunctive to appropriate systemic therapy and overall osteoporosis management as directed by the patient's treating physicians.
Other Name: AGN1 Femoral LOEP™
- Number of participants with procedure-related or device-related adverse events [ Time Frame: 42 Days ]
Adverse Events and Serious Adverse Events related to either the treatment or device.
The incidence of all adverse events occurring during the first forty-two (42) day follow-up period determined to be at least possibly related to the procedure and/or device for the local treatment of osteoporosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916953
|Contact: Ruth Cheng, PhDemail@example.com|
|Contact: Joris Coteur, MSfirstname.lastname@example.org|
|Dendermonde, Belgium, 9200|
|Contact: Govaers, MD|
|Principal Investigator: Kris Govaers, MD|
|AZ Maria Middelares||Recruiting|
|Ghent, Belgium, 9000|
|Contact: Van Overschelde, MD|
|Principal Investigator: Philippe Van Overschelde, MD|
|AZ Groeninge - Campus Kennedylaan||Recruiting|
|Kortrijk, Belgium, 8500|
|Contact: Putzeys, MD|
|Principal Investigator: Guy Putzeys, MD|
|Sint-Niklaas, Belgium, 9110|
|Principal Investigator: Jo De Schepper, MD|
|Maastricht, Netherlands, 6229|
|Contact: ten Broeke, MD|
|Principal Investigator: R.H.M. ten Broeke, MD|
|Principal Investigator:||Jo De Schepper, MD||AZ Nikolaas|