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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
Sponsor:
Collaborators:
KCR S.A.
genae Group
Information provided by (Responsible Party):
AgNovos Healthcare, LLC

Brief Summary:
The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.

Condition or disease Intervention/treatment Phase
Osteoporosis Device: AGN1 Femoral Local Osteo-Enhancement Procedure Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Treatment
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™




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is postmenopausal female (at least 1-year post menses).
  2. Subject has osteoporosis as defined by a documented DXA scan T score of ≤ -2.5 in the femoral neck of at least one hip within the last year. If no documented T-score, then a DXA scan will be performed during eligibility screening.
  3. Subject has one hip without previous surgery or fracture.
  4. Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
  5. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  6. Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

  1. Subject is less than six (6) months removed from having a hip fracture repair or prosthesis, or less than three (3) months removed from an elective THA.
  2. Subject has progressive increase in undiagnosed hip pain over the previous six months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. rheumatoid arthritis, fracture, etc.).
  3. Subject is dependent on the use of a wheel-chair or is bed-ridden.
  4. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia).
  5. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min or is being treated with dialysis.
  6. Subject has insulin-dependent diabetes mellitus (IDDM).
  7. Subject has Body Mass Index (BMI) > 35.
  8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*.
  9. Subject exhibits excessive alcohol consumption as determined by the principal investigator*.
  10. Subject has radiological evidence of gross bony or joint pathology, including signs predictive of atypical femoral fractures (e.g. Cortical beaking) or has been diagnosed and/or treated for atypical femoral fractures.
  11. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
  12. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
  13. Subject has history of metabolic bone disease other than osteoporosis (ex. Paget's disease).
  14. Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
  15. Subject has a history of radiation therapy to the hip or pelvic region.
  16. Subject has a history of any invasive malignancy (except basal cell carcinoma), unless treated and with no clinical signs of symptoms of malignancy for five (5) years.
  17. Subject has known allergies to implanted device.
  18. 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.
  19. Subject is currently enrolled in another clinical study. *AgNovos's recommendation is >1 pack per day smoking and >3 alcoholic drinks per day

Information from the National Library of Medicine

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


Contacts
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Contact: Ruth Cheng, PhD 240-753-6432 rcheng@agnovos.com
Contact: Joris Coteur, MS 0032473252806 jcoteur.consultant@agnovos.com

Locations
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Belgium
AZ Sint-Blasius Recruiting
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         
AZ Sint-Nikolaas Recruiting
Sint-Niklaas, Belgium, 9110
Contact: Bulterys         
Principal Investigator: Jo De Schepper, MD         
Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands, 6229
Contact: ten Broeke, MD         
Principal Investigator: R.H.M. ten Broeke, MD         
Sponsors and Collaborators
AgNovos Healthcare, LLC
KCR S.A.
genae Group
Investigators
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Principal Investigator: Jo De Schepper, MD AZ Nikolaas

Additional Information:
Publications:
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Responsible Party: AgNovos Healthcare, LLC
ClinicalTrials.gov Identifier: NCT02916953     History of Changes
Other Study ID Numbers: PRE-EU-101.1
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decision on what data to share has not yet been determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases