Status:
RECRUITING
IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
IlluminOss Medical, Inc.
University of Miami
Conditions:
Cancer Metastatic
Trauma
Eligibility:
All Genders
21+ years
Brief Summary
The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants in patients with pelvic metastatic disease presenting with pain, risk of pathologic fracture, non-displaced or ...
Detailed Description
The matrix morphology of the tumors in metastatic bone disease (MBD) may be of blastic, lytic, or mixed characteristics. Cancers of purely lytic or mixed blastic-lytic composition are the most concern...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients are being targeted because they have already agreed to the undergo the IlluminOss Pelvic Implant for standard clinical care. It is a decision made by the treating surgeon separately from research and prior to mention of the study.
- Patient is a skeletally mature patient 21 years of age or older (closed epiphyseal plates) who receiving the FDA-approved IlluminOss Pelvic Implant
- IlluminOss Pelvic Implant is intended to treat pain due to impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis secondary to metastatic malignancy, multiple myeloma, lymphoma, or radiation osteitis or a pelvic fragility fracture in a geriatric patients (age 65 or older)
- VAS Pain Score ≥ 30 on 0 to 100 scale
- Exclusion criteria:
- Patient is uncooperative, or patient incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder)
- Patient is a prisoner
- Patient is deemed surgically unfit by the medical oncology service
Exclusion
Key Trial Info
Start Date :
November 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04842266
Start Date
November 18 2021
End Date
December 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114