Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-31 @ 4:26 AM
Study NCT ID:
NCT06257368
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TFL Driven Urinary System Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 373}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Laser ON', 'timeFrame': 'day 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is:\n\nTo assess the use of Coloplast TFL Drive in daily practice\n\nTo confirm:\n\n* the safety and efficacy of the Coloplast TFL Drive and its GUI (Graphical User Interface) with pre-embedded settings in Laser lithotripsy\n* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia\n* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for ablation of urological tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients, male and female with an urological disease for which TFL treatment is indicated.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any adult patient, for which TFL laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, BPH (Benign Prostate Hypertrophy…)\n\nExclusion Criteria:\n\n* Any condition when TFL laser should not be indicated as per the TFL user manual (untrained surgeon on laser use, patient's conditions)\n* Patients with no signed consent form\n* Patients \\<18 years old\n* Patients under tutorship or guardianship\n* Patients who already took part in the study\n* Pregnant or breastfeeding women\n* Patient undergoing 2nd step laser procedure at inclusion\n* Subject already included in another study"}, 'identificationModule': {'nctId': 'NCT06257368', 'acronym': 'TFL-DUST', 'briefTitle': 'TFL Driven Urinary System Treatment Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'TFL-DUST Study TFL Driven Urinary System Treatment Study', 'orgStudyIdInfo': {'id': 'CP359'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coloplast TFL Drive', 'type': 'DEVICE', 'description': 'Thulium Fiber laser'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire Robert, pr', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor Tostivint, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Jules Verne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Traxer, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24000', 'city': 'Périgueux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Richard Mallet, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé Francheville', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Romero-Otero, Dr', 'role': 'CONTACT'}], 'facility': 'HM Hospital Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Jessica Heringer', 'role': 'CONTACT', 'email': 'frhej@coloplast.com', 'phone': '+33644287794'}], 'overallOfficials': [{'name': 'Isabelle D de Berny', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coloplast Manufacturing France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}