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| Name | Class |
|---|---|
| AdventHealth | OTHER |
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This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.
Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J-Plasma | Experimental | Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J-Plasma | Device | Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of Lymphocele Formation | The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Must answer no to all:
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| Name | Affiliation | Role |
|---|---|---|
| Vipul R Patel, MD | Florida Hospital Global Robotics Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Global Robotics Institute | Celebration | Florida | 34747 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | J-Plasma | Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | J-Plasma | Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Incidence of Lymphocele Formation | The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound. | Posted | Count of Participants | Participants | 12 weeks |
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Adverse events were collected beginning at the day of surgery and collected to the 8 week follow-up visit (8 weeks, +/- 4 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | J-Plasma | Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Larson | Apyx Medical | 8012440058 | kari.larson@apyxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2016 | Jul 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008210 | Lymphocele |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Pre-Op Prostate-Specific Antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| Pre-Operative Biopsy Gleason | Gleason scores range from 2 to 10, and most prostate cancer will score 6 or higher. A higher score (8 to 10) means the type of cancer has a higher risk of growing and spreading. | Mean | Standard Deviation | units on a scale (Scale 2 - 10) |
|
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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