Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced U… (NCT01732991) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
France12 participantsStarted 2012-09
Plain-language summary
The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the treatment of benign prostatic hypertrophy (BPH) as recommended.
The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced ultrasound the necrosis.
Who can participate
Age range
18 Years
Sex
MALE
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:
* Patient over 40 years old without an upper age limit
* Informed orally and in writing, having signed a consent which match to the research
* Patient with a benign prostatic hypertrophy requiring surgical treatment by PVP
* Person affiliated to a social security system
Exclusion Criteria:
* Contraindications to MRI for patients with:
* ocular metallic foreign object
* any electronic medical device implanted by irremovable way (pacemakers, neuro-stimulator, cochlear implants ...)
* metallic heart valve, old heart valves are specially an absolute contraindication because of risk of dysfunction
* vascular clips implanted formerly on brain aneurysm
* Allergy to Gadolinium
* Contraindications to the contrast medium Sonovue:
* Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue
* Recent acute coronary syndrome (within 6 months before the intervention)
* Unstable ischemic heart disease (myocardial infarction being formed or evolving, typical angina of rest in the previous month)
* Significant worsening of cardiac symptoms between the pre anaesthesia consultation and intervention
* Recent intervention (less than 6 months) on coronary arteries or other factor suggesting clinical instability (changes in ECG, changes in clinical or biological parameters)
* Acute heart failure or heart failure stage III or IV
* Severe arrhythmias
* Right-left shunt
* Acute endocarditis
* Valve prothesis
* Severe pulmonary …
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
1
Evolution of thickness of the average necrotic area
Timeframe: J0 (immediately after surgery) M1, M6 and M12