Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 12:23 AM
Study NCT ID:
NCT07350005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in parallel to one of three intervention arms corresponding to Holmium:YAG, Thulium:YAG, or Thulium Fiber Laser-based anatomical prostate enucleation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laser Enucleation Efficiency (g/J)', 'timeFrame': 'Intraoperative', 'description': 'Laser enucleation efficiency will be evaluated by calculating the amount of enucleated prostate tissue in grams per joule of laser energy used (g/J), based on intraoperative laser system data and enucleated tissue weight recorded during surgery.'}], 'secondaryOutcomes': [{'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline (preoperative) and 3 months postoperatively', 'description': 'Change in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up will be evaluated to assess functional outcomes after prostate enucleation.'}, {'measure': 'Postoperative Urinary Incontinence', 'timeFrame': 'Up to 3 months postoperatively', 'description': 'The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bph', 'prostate', 'holmium', 'thulium', 'TFL'], 'conditions': ['BPH (Benign Prostatic Hyperplasia)']}, 'descriptionModule': {'briefSummary': 'Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH.\n\nThe purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation.\n\nThe primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence.\n\nAll laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes', 'detailedDescription': 'This is a prospective, randomized, single-center clinical study designed to compare the efficiency and safety of three different laser systems used in anatomical prostate enucleation for the surgical treatment of benign prostatic hyperplasia (BPH).\n\nEligible patients will be randomly assigned to undergo prostate enucleation using one of the following laser technologies: Holmium:YAG laser, Thulium:YAG laser, or Thulium Fiber Laser (TFL). All procedures will be performed according to standard surgical techniques routinely used in clinical practice.\n\nThe primary outcome of the study is laser efficiency, which will be evaluated using intraoperative laser system data,including grams of enucleated prostate tissue per joule (g/J). Preoperative prostate volume and intraoperative laser parameters are routinely recorded and will be used for analysis. No additional diagnostic procedures or treatments will be performed specifically for study purposes.\n\nSecondary outcomes include changes in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up and the presence of postoperative urinary incontinence. Safety assessment will be based on perioperative and postoperative adverse events recorded during routine clinical care.\n\nThe study will be conducted in accordance with ethical principles and applicable regulatory requirements, and patient confidentiality will be maintained throughout the study period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Individuals of any gender identity who have a prostate and meet the clinical eligibility criteria for prostate enucleation surgery are eligible to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for anatomical prostate enucleation\n* Presence of a prostate and clinical indication for surgical treatment\n* Age between 50 and 80 years\n\nExclusion Criteria:\n\n* History or suspicion of prostate cancer\n* Previous prostate surgery\n* Presence of neurogenic bladder or significant lower urinary tract dysfunction unrelated to BPH\n* Active urinary tract infection at the time of surgery\n* Severe comorbid conditions contraindicating surgery or anesthesia'}, 'identificationModule': {'nctId': 'NCT07350005', 'acronym': 'TRI-LASER', 'briefTitle': 'Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation', 'orgStudyIdInfo': {'id': 'AUTF-TRI-LASER-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Holmium:YAG Laser Enucleation', 'description': 'Participants in this arm will undergo anatomical prostate enucleation using Holmium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.', 'interventionNames': ['Procedure: Holmium:YAG Laser Prostate Enucleation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thulium:YAG Laser Enucleation', 'description': 'Participants in this arm will undergo anatomical prostate enucleation using Thulium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.', 'interventionNames': ['Procedure: Thulium:YAG Laser Prostate Enucleation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thulium Fiber Laser (TFL) Enucleation', 'description': 'Participants in this arm will undergo anatomical prostate enucleation using Thulium Fiber Laser (TFL) as part of standard surgical treatment for benign prostatic hyperplasia.', 'interventionNames': ['Procedure: Thulium Fiber Laser Prostate Enucleation']}], 'interventions': [{'name': 'Holmium:YAG Laser Prostate Enucleation', 'type': 'PROCEDURE', 'description': 'Anatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.', 'armGroupLabels': ['Holmium:YAG Laser Enucleation']}, {'name': 'Thulium:YAG Laser Prostate Enucleation', 'type': 'PROCEDURE', 'description': 'Anatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.', 'armGroupLabels': ['Thulium:YAG Laser Enucleation']}, {'name': 'Thulium Fiber Laser Prostate Enucleation', 'type': 'PROCEDURE', 'description': 'Anatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.', 'armGroupLabels': ['Thulium Fiber Laser (TFL) Enucleation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Ilker Gokce, Prof.', 'role': 'CONTACT', 'email': 'migokce@ankara.edu.tr', 'phone': '+90 312 508 35 67'}, {'name': 'MEHMET EROL maras, resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ahmet furkan ozsoy, resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mehmet Erol Maras, Resident', 'role': 'CONTACT', 'email': 'mehmeterolmaras@gmail.com', 'phone': '+90 552 666 6220'}, {'name': 'Ahmet Furkan Ozsoy, Resident', 'role': 'CONTACT', 'phone': '+90 531 635 29 25'}], 'overallOfficials': [{'name': 'Mehmet Ilker Gokce, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 6 months after publication and ending 5 years after publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.', 'accessCriteria': 'Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'erol maraş', 'investigatorAffiliation': 'Ankara University'}}}}