Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02346500
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2013-10-28
Brief Title:
Ultrasound-Guided Photoselective Vaporization of the Prostate
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Ultrasound-Guided Photoselective Vaporization of the Prostate
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Benign prostatic hyperplasia BPH is a major cause of lower urinary tract symptoms LUTS affecting aging men Medical therapy for BPH includes alpha adrenergic blockers and 5α-reductase inhibitors In men with moderate-severe LUTS due to BPH surgical therapy should be considered for 1 those who failed medical therapy andor 2 those with refractory urinary retention renal insufficiency secondary to BPH recurrent urinary tract infections UTIs or bladder stones The gold standard for the surgical therapy of BPH has been transurethral resection of the prostate TURP However TURP is associated with significant comorbidities such as bleeding prolonged catheterization and absorptional hyponatremia To minimize these problems associate with TURP alternative minimally invasive treatment techniques have been developed Two of the most commonly used treatment modalities include a photoselective laser vaporization of the prostate GreenLight PVP using the potassium titanyl phosphate KTP laser and holmium laser enucleation of prostate HoLEP The major problem in all these minimally invasive treatment modalities is that they are generally associated with a higher retreatment rate In addition there is no intraoperative and objective measurement other than a limited transurethral visualization of the prostatic cavity to assess the extent of the vaporization or enucleation
We propose to use the transrectal ultrasound TRUS and a novel robot the TRUS robot to hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation of the prostate gland intraoperatively TRUS has been extensively used for the biopsy needle guidance during prostate biopsy However it has never been used during transurethral prostate procedure The TRUS Robot has been used safely in the current clinical trial NA_00027540 Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy We would like to study the feasibility and safety of using TRUS and the TRUS Robot to monitor the minimally invasive treatment of BPH such as GreenLight PVP
We propose to use the transrectal ultrasound TRUS and a novel robot the TRUS robot to hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation of the prostate gland intraoperatively TRUS has been extensively used for the biopsy needle guidance during prostate biopsy However it has never been used during transurethral prostate procedure The TRUS Robot has been used safely in the current clinical trial NA_00027540 Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy We would like to study the feasibility and safety of using TRUS and the TRUS Robot to monitor the minimally invasive treatment of BPH such as GreenLight PVP
Detailed Description:
In the current pilot safety and feasibility SF study for ultrasound-guided PVP UG-PVP we propose to use TRUS and the TRUS-Robot to record ultrasound images during PVP in 10 patients The PVP procedure will be conducted as usual without using the ultrasound for guiding the intervention TRUS images of the prostate gland and the intraprostatic cavity formed during the PVP procedure will be recorded These will include three dimensional 3-D images acquired at the beginning and end of the operation In addition real-time 2-D images will be recorded during the case Recorded images will then be analyzed offline to observe the extent of the vaporization or enucleation of the prostate gland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None