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CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis

NCT02916953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • KCR S.A.

    collaborator UNKNOWN

  • genae Group

    collaborator UNKNOWN

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Jo De Schepper, MD · AZ Nikolaas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-17
Primary Completion
2021-06-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916953 on ClinicalTrials.gov