Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

NCT ID: NCT04580628

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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While prostate laser enucleation is being confirmed as the new gold standard for surgical management of benign prostate hypertrophy, the holmium:Yag laser is currently the most widely used. A new laser technology, the fibrous thulium laser (TFL), has recently appeared with clearly superior results for lithotripsy. The question therefore arises of the surgical and functional results of the use of fibrous thulium for prostate enucleation.

Conditions

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Prostate Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint-Hilaire

OTHER

Sponsor Role lead

Responsible Party

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MALVAL Benoit

Principal Investigator, Doctor in urology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BENOIT MALVAL

Role: PRINCIPAL_INVESTIGATOR

Clinique Saint-Hilaire

Locations

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Clinique Saint Hilaire

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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202000549

Identifier Type: -

Identifier Source: org_study_id

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