Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic Bone Stabilization System | Experimental | Photodynamic Bone Stabilization System (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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System | Device | Treatment of impending and actual pathological fractures of the humerus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain). | Baseline and 90 days |
| Change in Function | Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | Baseline and 90 days |
| Summary of Clinical Safety Success | No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation | Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Palpation | Pain on palpation and clinical significance | 90, 180 and 360 days |
| Duration of Index Procedure | Duration of index procedure (hours) |
Not provided
Inclusion Criteria:
- General 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:
Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
VAS Pain Score > 60mm on 100mm scale.
-Impending Fracture-Specific Inclusion Criteria
Documented presence of at least one metastatic lesion of the humerus.
Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements)
Destruction of cortical bone at impending fracture site > 50%.
-Actual Fracture-Specific Inclusion Criteria
Fracture is closed, Gustilo Type I or II.
Exclusion Criteria:
- General 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.
Active or incompletely treated infections that could involve the device implant site.
Distant foci of infection that may spread to the implant site.
Allergy to implant materials or dental glue.
In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
Prisoner
-Impending Fracture-Specific Exclusion Criteria
Mirels Score < 8 (specific to target humeral lesion).
Destruction of cortical bone at impending fracture site < 50%.
Prior surgery and/or prior fracture of affected site.
Any articular component to impending fracture site.
-Actual Fracture-Specific Exclusion Criteria
Open fractures with severe contamination.
Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford School of Medicine | Redwood City | California | 94063 | United States | ||
| MedStar Washington Hospital Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2016 | Jan 3, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 Day |
| Activities of Daily Living Score Through All Follow-up Intervals | Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning. | Baseline, 90, 180 and 360 days |
| MSTS Upper Extremity Functional Outcome | Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | 90, 180, 360 days |
| Assessment of Post-Surgery Status | Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication | Surgery & Discharge, 7-14, 30, 90, 180, 360 days |
| Summary of Procedure and Device-Related Complications Rate | Procedure and device-related complications rate presented at follow-up visits | up to day 90, up to day180 since day 90, up to 360 since day 180 |
| Summary of Change From Baseline Range of Motion by Visit and Test | Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm. | Baseline, 90, 180 and 360 Days |
| Length of Hospital Stay | Length of hospital stay (from day of procedure to day of discharge) | From day of procedure until the day of hospital discharge (up to 36 days) |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| MedStar Franklin Square Medical Center | Baltimore | Maryland | 21237 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh Physicians | Pittsburgh | Pennsylvania | 15232 | United States |
| University Orthopedics Inc. | Providence | Rhode Island | 02905 | United States |
| Marshall University | Huntington | West Virginia | 25701 | United States |
| Enrolled |
|
| Device Implanted |
|
| Treatment Failure |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Actual Bone Fracture Characteristics - Location of Target Fracture | Subjects with Actual Bone Fracture | Count of Participants | Participants |
| |||||||||||||||||
| Actual Bone Fracture Characteristics - Location | Subjects with Actual Bone Fracture | Count of Participants | Participants |
| |||||||||||||||||
| Actual Bone Fracture Characteristics - AO Classification | Classification system of fractures. 11 is the proximal humerus, 12 is the humeral shaft, and 13 is the distal humerus. For the proximal humerus, A is an extra-articular unifocal fracture, B is an extra-articular bifocal fracture and C is an articular fracture. For the humeral shaft, A is a simple fracture, B is a wedge fracture and C is a complex fracture. For the distal humerus, A is an extra articular fracture, B is partial articular fracture and C is a complete articular fracture. These are further classified as 1, 2, 3 with the higher number indicating a more complex fracture. | Subjects with Actual Bone Fracture | Count of Participants | Participants |
| ||||||||||||||||
| Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue | Soft tissue grading. It ranges from Type I (wound < 1 cm) to Type III C (vascular injury requiring vascular repair), with the wound damage getting more severe as the type increases. A closed fracture does not have any soft tissue damage. The grading system considers the energy of the injury, the wound size, amount of soft tissue damage, contamination, fracture pattern, periosteal stripping, skin coverage, neovascular injury and antibiotic use. | Subjects with Actual Bone Fracture | Count of Participants | Participants |
| ||||||||||||||||
| Impending Bone Fracture Characteristics - Location of Target Fracture | Subjects with Impending Bone Fracture | Count of Participants | Participants |
| |||||||||||||||||
| Impending Bone Fracture Characteristics - Location | Subjects with Impending Bone Fracture | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain | Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain). | Number of subjects who had a Day 90 visit | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 90 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Function | Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | Subjects who had 90 Day data | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Summary of Clinical Safety Success | No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation | Posted | Count of Participants | Participants | Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pain at Palpation | Pain on palpation and clinical significance | Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit. | Posted | Count of Participants | Participants | 90, 180 and 360 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Index Procedure | Duration of index procedure (hours) | Posted | Mean | Standard Deviation | hours | 1 Day |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Activities of Daily Living Score Through All Follow-up Intervals | Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning. | Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 90, 180 and 360 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MSTS Upper Extremity Functional Outcome | Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit. | Posted | Mean | Standard Deviation | units on a scale | 90, 180, 360 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Post-Surgery Status | Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication | Posted | Count of Participants | Participants | Surgery & Discharge, 7-14, 30, 90, 180, 360 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Procedure and Device-Related Complications Rate | Procedure and device-related complications rate presented at follow-up visits | Posted | Count of Participants | Participants | up to day 90, up to day180 since day 90, up to 360 since day 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Change From Baseline Range of Motion by Visit and Test | Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm. | Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit. | Posted | Mean | Standard Deviation | degrees | Baseline, 90, 180 and 360 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | Length of hospital stay (from day of procedure to day of discharge) | Posted | Mean | Standard Deviation | Days | From day of procedure until the day of hospital discharge (up to 36 days) |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus | 32 | 81 | 58 | 81 | 49 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Medical device site pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Post procedural pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chondrosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endotheliomatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Large cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Leiomyosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Activities of daily living impaired | Social circumstances | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Medical device site pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Medical device site swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
The PI shall submit copies of any material to sponsor for review at least 30 days in advance of submission to a publisher or other third party. The sponsor shall review the data provided for consistency and reserves the right to delete any confidential information or other proprietary information from the proposed material. Sponsor may extend such review period for another 60 days to allow for filing of patent applications or take other steps to protect the sponsor's IP interests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gene DiPoto | IlluminOss Medical Inc. | 401-714-0008 | 202 | gdipoto@illuminoss.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2016 | Jan 3, 2018 | SAP_001.pdf |
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Right Humerus |
|
| Diaphyseal |
|
| Distal |
|
| 11-A2 |
|
| 11-A3 |
|
| 12-A1 |
|
| 12-A2 |
|
| 12-A3 |
|
| 12-B1 |
|
| 12-B2 |
|
| 12-C3 |
|
| NA |
|
| Unknown |
|
| Type I |
|
| Right Humerus |
|
| Diaphyseal |
|
| Distal |
|
| Superiority |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Pain on palpation Not Done |
|
|
| Pain on palpation Not Done |
|
| None |
|
| None |
|