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A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

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ClinicalTrials.gov Identifier: NCT02373904
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.

Study Description
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Brief Summary:
The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.

Condition or disease Intervention/treatment Phase
Humerus Pathological Fracture Device: Photodynamic Bone Stabilization System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease
Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Photodynamic Bone Stabilization System (PBSS)
The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone.
 Device: Photodynamic Bone Stabilization System
Treatment of impending and actual pathological fractures of the humerus


Outcome Measures
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Primary Outcome Measures :
  1. Pain Reduction [ Time Frame: 90 days ]
    VAS Pain Score change of > -33% compared to baseline

  2. Functional Improvement (Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) [ Time Frame: 90 days ]
    • Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline
    • EORTC QLQ-C30 improvement of > +10% from baseline
    • EORTC QLQ-BM22 improvement of > +10% from baseline

  3. Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) [ Time Frame: 90 days ]
    • No Serious Device Related Complications
    • No additional surgical interventions: revisions, supplements, fixations or removals

  4. Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) [ Time Frame: 90 days ]
    No device fracture, migrations, mal-alignment or loss of reduction or fixation


Secondary Outcome Measures :
  1. Pain Reduction (VAS Pain Score change of > -33% compared to baseline) [ Time Frame: 90, 180 and 360 days ]
    VAS Pain Score change of > -33% compared to baseline

  2. Functional Improvement (-Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) [ Time Frame: 90, 180, 360 days ]
    • Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline,
    • EORTC QLQ-C30 improvement of > +10% from baseline
    • EORTC QLQ-BM22 improvement of > +10% from baseline

  3. Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) [ Time Frame: 90, 180, 360 days ]
    • No Serious Device Related Complications
    • No additional surgical interventions: revisions, supplements, fixations or removals

  4. Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) [ Time Frame: 90, 180, 360 days ]
    No device fracture, migrations, mal-alignment or loss of reduction or fixation

  5. Duration of index procedure and length of hospital stay [ Time Frame: 90, 180, 360 days ]
  6. Disability status [ Time Frame: 90, 180, 360 days ]
    Determined per Investigator assessment

  7. Evaluation of duration of physical therapy prescription [ Time Frame: 90, 180, 360 days ]
  8. Assessment of prescription and over-the-counter analgesic medication use [ Time Frame: 90, 180, 360 days ]
  9. Survivability from time of index procedure to death [ Time Frame: 90, 180, 360 days ]
  10. Incidence and number of AEs [ Time Frame: 90, 180, 360 days ]
  11. Incidence and number of procedure- and device-related complications [ Time Frame: 90, 180, 360 days ]
  12. Activities of Daily Living score through all follow-up intervals [ Time Frame: 90, 180, 360 days ]
    Barthel Index of Activities of Daily Living (ADLs), EORTC QLQ-C30 and EORTC QLQ-BM22

  13. VAS Pain score from baseline through all follow-up intervals [ Time Frame: 90, 180, 360 days ]
    VAS pain scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-General Inclusion Criteria

  1. Skeletally mature adult males and females 18 years of age or older.
  2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.

  3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:

    1. Postmenopausal for at least 1 year OR
    2. Documented oophorectomy or hysterectomy
    3. Surgically sterile OR
    4. 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
  4. Able to understand and provide informed consent.

  5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.

    -Impending Fracture-Specific Inclusion Criteria

  6. Documented presence of solitary metastatic lesion.
  7. Mirels Criteria Score ≥ 8.

  8. Destruction of cortical bone at impending fracture site > 50%.

    -Actual Fracture-Specific Inclusion Criteria

  9. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2.
  10. Fracture is closed, Gustilo Type I or IIA.

Exclusion Criteria:

-General Exclusion Criteria

  1. Primary tumor (osteogenic origin, etc.) at site.
  2. Impending fracture or actual fracture location other than humerus.
  3. Current concomitant traumatic fracture of any other location.
  4. Active or incompletely treated infections that could involve the device implant site.
  5. Distant foci of infection that may spread to the implant site.
  6. Allergy to implant materials or dental glue.
  7. Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.

  8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).

    -Impending Fracture-Specific Exclusion Criteria

  9. Mirels Score < 8.
  10. Destruction of cortical bone at impending fracture site < 50%.
  11. Prior surgery and/or prior fracture of affected site.

  12. Any articular component to impending fracture site.

    -Actual Fracture-Specific Exclusion Criteria

  13. Index treatment is greater than 28 days post fracture.
  14. Open fractures with severe contamination.
  15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
  16. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
  17. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
Contacts and Locations
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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): NCT02373904


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Germany
St. Vinzenz-Hospital GmbH
Koln, Germany, D-50733
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Lahn-Dill Kliniken
Wetzlar, Germany, 35578
Netherlands
Medisch Spectrum Twente
Enschede, Netherlands, 7513 ER
Medical Center Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Sponsors and Collaborators
IlluminOss Medical, Inc.
More Information
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Responsible Party: IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier: NCT02373904    
Other Study ID Numbers: 14-03-PATHOLHUM-01
NL49653.072.14 ( Other Identifier: Institutional Review Board Nijmegen )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Bone Diseases
Fractures, Bone
Fractures, Spontaneous
Wounds and Injuries
Musculoskeletal Diseases