Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 11:47 AM
Study NCT ID:
NCT05814133
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thulium Fiber Laser Prospective Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean length of hospitalization', 'timeFrame': 'From day and time of admission to day and time of discharge', 'description': 'Length of hospitalization (in days) for the procedure will be recorded for each patient'}, {'measure': 'Rate of postoperative complications', 'timeFrame': 'at 6 weeks', 'description': 'Medical chart review will be done to assess the occurence of post-operative complications'}, {'measure': 'Rate of stone free status', 'timeFrame': 'at 6 weeks', 'description': "Post-operative CT imaging will be reviewed to assess the occurence of ''stone free status''"}, {'measure': 'Rate of need for ancillary procedures', 'timeFrame': 'at 6 weeks', 'description': 'Medical chart review will be done to assess the occurence of an additional ureteroscopy need to treat patients'}, {'measure': 'Mean perceived workload score', 'timeFrame': 'immediately after the procedure', 'description': 'Effects of TFL technology on reducing surgeon perceived workload will be assessed by completing the National Aeronautics and Space Administration (NASA) Task Load Index. The tool allows to determine the subjective mental workload (MWL) of a participant while they are performing a task.The participants self-rate on a scale of 1 (low) to 20 (high). The higher the score, the worst is the outcome.'}], 'primaryOutcomes': [{'measure': 'Mean total operative time', 'timeFrame': 'during the procedure', 'description': 'Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.'}], 'secondaryOutcomes': [{'measure': 'Rate of stone retropulsion', 'timeFrame': 'during the procedure', 'description': 'Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ureteroscopy', 'lithotripsy', 'thulium fiber laser'], 'conditions': ['Kidney Stone']}, 'referencesModule': {'references': [{'pmid': '25185524', 'type': 'BACKGROUND', 'citation': 'Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.'}, {'pmid': '15659912', 'type': 'BACKGROUND', 'citation': 'Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.'}, {'pmid': '33660440', 'type': 'BACKGROUND', 'citation': 'Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.'}, {'pmid': '33470684', 'type': 'BACKGROUND', 'citation': 'Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.'}, {'pmid': '34362169', 'type': 'BACKGROUND', 'citation': 'Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.'}, {'pmid': '30614878', 'type': 'BACKGROUND', 'citation': 'Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.'}], 'seeAlsoLinks': [{'url': 'http://www.urotoday.com/conference-highlights/aua-2019-annual-meeting/aua-2019-stone-disease/112422-aua-2019-comparison-of-dusting-and-fragmenting-using-the-new-super-pulse-thulium-fiber-laser-to-a-120w-holmium-yag-laser.html', 'label': 'Chew \\* Ben H., Knudsen BE, Molina WR. Mp79-19 comparison of dusting and fragmenting using the new super pulse thulium fiber laser to a 120w holmium:yag laser. Journal of Urology. 2019 Apr;201(Supplement 4):e1159-60.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.', 'detailedDescription': "Flexible ureteroscopy is considered the first-line therapy for renal stones \\< 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required\n* Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines\n* Must be 18 years or older\n* Must be able to give consent\n* Bilateral ureteroscopy will be permitted but only the first side will be included in the study\n\nExclusion Criteria:\n\n* Concomitant stones in the ureter\n* Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture\n* Prior radiotherapy to the abdomen or pelvis\n* Neurogenic bladder or spinal cord injury\n* Pregnancy\n* Untreated Urinary Tract Infection (UTI)'}, 'identificationModule': {'nctId': 'NCT05814133', 'acronym': 'TFL', 'briefTitle': 'Thulium Fiber Laser Prospective Trial', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis', 'orgStudyIdInfo': {'id': '2023-11370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lithotripsy', 'description': 'Ureteroscopy with lithotripsy using the Thulium Fiber Laser', 'interventionNames': ['Device: Thulium Fiber Laser']}], 'interventions': [{'name': 'Thulium Fiber Laser', 'type': 'DEVICE', 'description': 'Thulium Fiber Laser will be used to break renal stones \\< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.', 'armGroupLabels': ['Lithotripsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Naeem Bhojani, MD', 'role': 'CONTACT', 'email': 'naeem.bhojani@gmail.com'}, {'name': 'Kahina Bensaadi', 'role': 'CONTACT', 'email': 'kahina.bensaadi.chum@ssss.gouv.qc.ca'}, {'name': 'Naeem Bhojani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Naeem Bhojani, M.D', 'role': 'CONTACT', 'email': 'naeem.bhojani@gmail.com', 'phone': '5148908000', 'phoneExt': '22931'}, {'name': 'Kahina Bensaadi, DESS', 'role': 'CONTACT', 'email': 'kahina.bensaadi.chum@ssss.gouv.qc.ca', 'phone': '5148908000', 'phoneExt': '30824'}], 'overallOfficials': [{'name': 'Naeem Bhojani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}