Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery
PERSEE II
Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate
2 other identifiers
interventional
100
1 country
2
Brief Summary
This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Jan 2019
Shorter than P25 for not_applicable prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJanuary 28, 2019
November 1, 2018
1.4 years
May 22, 2018
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
pCLE criteria
Definition of pCLE criteria for normal and abnormal prostate tissues
1 year
Other Outcomes (4)
Ease of use of the endomicroscopy device
1 year
Audio/video telecommunication quality
1 year
Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
1 year
- +1 more other outcomes
Study Arms (1)
Confocal Laser Endomicroscopy
EXPERIMENTALAll included patients will undergo probe-based Confocal Laser Endomicroscopy during Robotic-Assisted Radical Prostatectomy (RARP) or Laparoscopic Radical Prostatectomy (LRP)
Interventions
The study is divided in 2 parts. 1. Ex vivo study * Prostate specimens will be stained using Fluorescein * Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired. 2. In vivo study * Intravenous injection of contrast agent * pCLE imaging every 5mm of the NVB dissection zone.
Eligibility Criteria
You may qualify if:
- Over 18 years
- Localised or locally advanced prostate cancer
- Agreement given for Radical Prostatectomy
- Not eligible or refusing an active surveillance protocol
- having given its signed informed consent
You may not qualify if:
- Under 18 years
- Previously treated for PCa (hormones, EBRT, focal treatments)
- Surgical history of BPH treatment
- Known allergy to Fluorescein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75012, France
Institut Mutualiste Montsouris
Paris, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Barret, MD
Institut Mutualiste Montsouris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 19, 2018
Study Start
January 16, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
January 28, 2019
Record last verified: 2018-11