NCT01732991

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 26, 2025

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

November 19, 2012

Last Update Submit

December 18, 2025

Conditions

Prostatic Hypertrophy, Benign

Keywords

Prostatic Hypertrophy, BenignGreenlight laserProstatic photovaporizationProstatic MRIProstatic contrast-enhanced ultrasoundUrinary irritative signsPostoperative necrotic area

Outcome Measures

Primary Outcomes (1)

  • Evolution of thickness of the average necrotic area

    The primary outcome measure is the measurement of the thickness of the average necrotic area in millimeters on prostatic monitoring MRI and contrast-enhanced ultrasound (no hypothesis in this descriptive study). The variables will be collected immediately after surgery as well as M1, M6 and M12.

    J0 (immediately after surgery) M1, M6 and M12

Secondary Outcomes (2)

  • Evolution of urinary irritative signs over 12 months

    J0, M1, M6 and M12

  • Evolution of prostatic volume over 12 months

    J0, M1, M6 and M12

Study Arms (1)

prostatic photo-vaporization

EXPERIMENTAL

prostatic photo-vaporization (PVP) surgery with laser Greenlight

Device: prostatic photo-vaporization (PVP)

Interventions

prostatic photo-vaporization (PVP)DEVICE

Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.

prostatic photo-vaporization

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Tours

Tours, 37044, France

Location

Related Publications (1)

  • Bruyere F, Bodin T, Bleuzen A, Patat F, Brunereau L. Penetration depth with the XPS GreenLight laser assessed by contrast enhanced ultrasonography. J Endourol. 2013 Oct;27(10):1282-6. doi: 10.1089/end.2013.0368. Epub 2013 Aug 21.

    PMID: 23837622RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Franck BRUYERE, MD

    CHRU TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 26, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 26, 2025

Record last verified: 2015-08

Locations

FR(1)