Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
Study NCT ID:
NCT06576661
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.', 'timeFrame': 'Procedure', 'description': 'Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \\& teamwork, and leadership.'}], 'secondaryOutcomes': [{'measure': 'Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores', 'timeFrame': 'Procedure', 'description': 'Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \\& teamwork, and leadership.'}, {'measure': 'Post-operative infection', 'timeFrame': '30-days post-operative', 'description': 'Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture'}, {'measure': 'Perioperative patient outcomes as measured by Clavien-Dindo classification system', 'timeFrame': 'Up to 30 days', 'description': 'Intraoperative complications will be categorized based on the Clavien-Dindo classification system'}, {'measure': 'Post-operative pain as measured by Visual analog scale (VAS)', 'timeFrame': 'Immediately post-operative and up to 7 days', 'description': 'The VAS is a valid and reliable method for quantifying pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain possible.'}, {'measure': 'Post-operative pain as measured by opioid use', 'timeFrame': 'Immediately post-operative and up to 7 days', 'description': 'Opioid usage will be tracked'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intrarenal Pressure', 'LithoVue Elite'], 'conditions': ['Kidney Stone', 'Nephrolithiasis']}, 'referencesModule': {'references': [{'pmid': '16857439', 'type': 'BACKGROUND', 'citation': 'Rogers SO Jr, Gawande AA, Kwaan M, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Analysis of surgical errors in closed malpractice claims at 4 liability insurers. Surgery. 2006 Jul;140(1):25-33. doi: 10.1016/j.surg.2006.01.008.'}, {'pmid': '15159366', 'type': 'BACKGROUND', 'citation': "Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, Etchells E, Ghali WA, Hebert P, Majumdar SR, O'Beirne M, Palacios-Derflingher L, Reid RJ, Sheps S, Tamblyn R. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004 May 25;170(11):1678-86. doi: 10.1503/cmaj.1040498."}, {'pmid': '16455321', 'type': 'BACKGROUND', 'citation': 'Yule S, Flin R, Paterson-Brown S, Maran N. Non-technical skills for surgeons in the operating room: a review of the literature. Surgery. 2006 Feb;139(2):140-9. doi: 10.1016/j.surg.2005.06.017.'}, {'pmid': '17054619', 'type': 'BACKGROUND', 'citation': "Yule S, Flin R, Paterson-Brown S, Maran N, Rowley D. Development of a rating system for surgeons' non-technical skills. Med Educ. 2006 Nov;40(11):1098-104. doi: 10.1111/j.1365-2929.2006.02610.x."}, {'pmid': '28723441', 'type': 'BACKGROUND', 'citation': 'Brunckhorst O, Volpe A, van der Poel H, Mottrie A, Ahmed K. Training, Simulation, the Learning Curve, and How to Reduce Complications in Urology. Eur Urol Focus. 2016 Apr;2(1):10-18. doi: 10.1016/j.euf.2016.02.004. Epub 2016 Feb 24.'}, {'pmid': '29915944', 'type': 'BACKGROUND', 'citation': 'Tokas T, Skolarikos A, Herrmann TRW, Nagele U; Training and Research in Urological Surgery and Technology (T.R.U.S.T.)-Group. Pressure matters 2: intrarenal pressure ranges during upper-tract endourological procedures. World J Urol. 2019 Jan;37(1):133-142. doi: 10.1007/s00345-018-2379-3. Epub 2018 Jun 18.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.", 'detailedDescription': "Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females over 18 years of age\n* Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney\n* Total stone burden over 2 cm\n\nExclusion Criteria:\n\n1. Undergoing bilateral stone treatment during the same procedure\n2. Patients with known genitourinary anatomical abnormalities\n3. Uncorrected coagulopathy\n4. Patients with urinary diversions\n5. Chronic external urinary catheters\n6. Women who are pregnant\n7. Immunosuppressed patients'}, 'identificationModule': {'nctId': 'NCT06576661', 'acronym': 'ELITE', 'briefTitle': 'Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes', 'orgStudyIdInfo': {'id': 'STUDY00160851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'URS WITH INTRARENAL PRESSURE MONITORING VISIBLE', 'description': 'In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.', 'interventionNames': ['Device: INTRARENAL PRESSURE MONITORING VISIBLE']}, {'type': 'NO_INTERVENTION', 'label': 'URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE', 'description': 'In Arm 2, participants will undergo URS LithoVue Elite™ without the real-time IRP monitoring information visible to the surgeon. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.'}], 'interventions': [{'name': 'INTRARENAL PRESSURE MONITORING VISIBLE', 'type': 'DEVICE', 'description': 'In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.', 'armGroupLabels': ['URS WITH INTRARENAL PRESSURE MONITORING VISIBLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jane Ledesma, BS', 'role': 'CONTACT', 'email': 'jledesma2@kumc.edu', 'phone': '913-588-8721'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Jane Ledesma', 'role': 'CONTACT', 'email': 'jledesma2@kumc.edu', 'phone': '19135888721'}], 'overallOfficials': [{'name': 'Bristol B Whiles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Bristol Whiles, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}