NCT04580628

Brief Summary

Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

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

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

September 19, 2020

Last Update Submit

March 8, 2022

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

    self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

    MONTH 12

Secondary Outcomes (29)

  • Rate of post-operative complications

    MONTH 6

  • duration of intervention

    POST SURGERY HOUR 24

  • bloodloss assessment

    Day 1

  • max flow assessment

    MONTH 12

  • max flow assessment

    MONTH 6

  • +24 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients treated at clinique saint hilaire Rouen with Thuflep, who consent

You may qualify if:

  • Patients superior or equal to 18 years old
  • Benign Prostate Hypertrophy ( more than 30cc.)
  • Indication to surgical treatment
  • No contraindication for surgery
  • No opposition to participating in the study

You may not qualify if:

  • Evidence of urethral stenosis
  • Evidence of a bladder tumour
  • Evidence of prostate cancer known or confirmed by prostate biopsies if suspected
  • Known neurological bladder
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint Hilaire

Rouen, 76000, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • BENOIT MALVAL

    Clinique Saint-Hilaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Doctor in urology department

Study Record Dates

First Submitted

September 19, 2020

First Posted

October 8, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

FR(1)