Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 12:55 AM
Study NCT ID:
NCT04580628
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2020-09-19', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL', 'timeFrame': 'MONTH 12', 'description': 'self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)'}], 'secondaryOutcomes': [{'measure': 'Rate of post-operative complications', 'timeFrame': 'MONTH 6', 'description': 'post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction'}, {'measure': 'duration of intervention', 'timeFrame': 'POST SURGERY HOUR 24', 'description': 'in minutes'}, {'measure': 'bloodloss assessment', 'timeFrame': 'Day 1', 'description': 'measurement of haemoglobinemia'}, {'measure': 'max flow assessment', 'timeFrame': 'MONTH 12', 'description': 'measured with urinary flowmeter in ml/sec'}, {'measure': 'max flow assessment', 'timeFrame': 'MONTH 6', 'description': 'measured with urinary flowmeter'}, {'measure': 'max flow assessment', 'timeFrame': 'MONTH 3', 'description': 'measured with urinary flowmeter'}, {'measure': 'max flow assessment', 'timeFrame': 'MONTH 1', 'description': 'measured with urinary flowmeter'}, {'measure': 'post-void residual (PVR) urine test', 'timeFrame': 'MONTH 12', 'description': 'ml'}, {'measure': 'post-void residual (PVR) urine test', 'timeFrame': 'MONTH 6', 'description': 'ml'}, {'measure': 'post-void residual (PVR) urine test', 'timeFrame': 'MONTH 3', 'description': 'ml'}, {'measure': 'post-void residual (PVR) urine test', 'timeFrame': 'MONTH 1', 'description': 'ml'}, {'measure': 'erectile dysfunction assessment', 'timeFrame': 'MONTH 12', 'description': 'self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction'}, {'measure': 'erectile dysfunction assessment', 'timeFrame': 'MONTH 6', 'description': 'self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction'}, {'measure': 'erectile dysfunction assessment', 'timeFrame': 'MONTH 3', 'description': 'self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction'}, {'measure': 'erectile dysfunction assessment', 'timeFrame': 'MONTH 1', 'description': 'self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction'}, {'measure': 'quality of life assessment', 'timeFrame': 'MONTH 12', 'description': 'self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)'}, {'measure': 'quality of life assessment', 'timeFrame': 'MONTH 6', 'description': 'self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)'}, {'measure': 'quality of life assessment', 'timeFrame': 'MONTH 3', 'description': 'self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)'}, {'measure': 'quality of life assessment', 'timeFrame': 'MONTH 1', 'description': 'self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)'}, {'measure': 'urinary incontinence Assessment', 'timeFrame': 'MONTH 12', 'description': 'self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks'}, {'measure': 'urinary incontinence Assessment', 'timeFrame': 'MONTH 6', 'description': 'self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks'}, {'measure': 'urinary incontinence Assessment', 'timeFrame': 'MONTH 3', 'description': 'self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks'}, {'measure': 'urinary incontinence Assessment', 'timeFrame': 'MONTH 1', 'description': 'self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks'}, {'measure': 'prostatic specific antigen in ng/mL level evolution', 'timeFrame': 'MONTH 1', 'description': 'ng/ml'}, {'measure': 'Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL', 'timeFrame': 'MONTH 1', 'description': 'self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)'}, {'measure': 'Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL', 'timeFrame': 'MONTH 3', 'description': 'self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)'}, {'measure': 'Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL', 'timeFrame': 'MONTH 6', 'description': 'self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)'}, {'measure': 'PATIENT GLOBAL IMPRESSION OF IMPROVEMENT', 'timeFrame': 'MONTH 1', 'description': 'SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)'}, {'measure': 'PATIENT GLOBAL IMPRESSION OF SEVERITY', 'timeFrame': 'MONTH 1', 'description': 'SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients treated at clinique saint hilaire Rouen with Thuflep, who consent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients superior or equal to 18 years old\n* Benign Prostate Hypertrophy ( more than 30cc.)\n* Indication to surgical treatment\n* No contraindication for surgery\n* No opposition to participating in the study\n\nExclusion Criteria:\n\n* Evidence of urethral stenosis\n* Evidence of a bladder tumour\n* Evidence of prostate cancer known or confirmed by prostate biopsies if suspected\n* Known neurological bladder\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04580628', 'briefTitle': 'Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Saint-Hilaire'}, 'officialTitle': 'Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)', 'orgStudyIdInfo': {'id': '202000549'}}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'BENOIT MALVAL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Saint-Hilaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Saint-Hilaire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Doctor in urology department', 'investigatorFullName': 'MALVAL Benoit', 'investigatorAffiliation': 'Clinique Saint-Hilaire'}}}}