CompletedNot Applicable

Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

United States81 participantsStarted 2015-03

Plain-language summary

This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Skeletally mature adult males and females 18 years of age or older.
. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:
. Postmenopausal for at least 1 year OR
. Documented oophorectomy or hysterectomy
. Surgically sterile OR
. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
. Patient, or his/her legally authorized representative, is able to understand and provide informed consent.

Exclusion criteria

. Primary tumor (osteogenic origin, etc.) at site.
. Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain

Timeframe: Baseline and 90 days

Change in Function

Timeframe: Baseline and 90 days

Summary of Clinical Safety Success

Timeframe: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360

Trial details

NCT IDNCT02338492

SponsorIlluminOss Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10

Results submitted2018-01-15

View on ClinicalTrials.gov More Humerus Fracture Metastatic Bone Disease trials