Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07296835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
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', 'interventionModelDescription': "This study employs a hybrid design: a prospective single-arm cohort of patients undergoing RIRS, with outcomes measured at predefined intervals. To provide comparative context, a retrospective control cohort will be identified from KUMC's electronic medical records of patients who also underwent RIRS by SOC with traditional f-URS scope, matched 2:1 based on key baseline characteristics (e.g., age, sex, stone size, etc.). This will allow for retrospective comparison of outcomes between the intervention group and standard management"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS', 'timeFrame': '36 months', 'description': 'Stone free rate, defined as the absence of residual stone fragments \\> 2 mm, as determined by noncontrast CT scan performed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hugemed, coast saving, ureteroscopy'], 'conditions': ['Kidney Stones']}, 'descriptionModule': {'briefSummary': 'Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ³ 18 years of age\n* Patients with ureteral or kidney stones undergoing primary flexible ureteroscopy for retrograde intrarenal surgery\n* Total stone burden ≤ 2.5 cm\n\nExclusion Criteria:\n\n* Undergoing bilateral stone treatment during the same procedure\n* Patients with known genitourinary anatomical abnormalities that would complicate the procedure as determined by the treating investigator\n* Uncorrected coagulopathy\n* Patients with urinary diversions\n* Chronic external urinary catheters\n* Women who are pregnant\n* Immunosuppressed patients\n* Non-elective procedures\n* Participants must not be involved in any other clinical research studies during the duration of this trial. Exceptions may be made if the investigator determines, on a case-by-case basis, that participation in another study will not adversely affect the outcomes or integrity of this trial'}, 'identificationModule': {'nctId': 'NCT07296835', 'briefTitle': 'Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope', 'orgStudyIdInfo': {'id': 'STUDY00161756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hugemed ureteroscopy', 'description': 'Patients scheduled to undergo URS retrograde intrarenal surgery per standard of care will be recruited from urology clinics or OR schedules using using the 6.3 Fr f-URS . Patients may be approached and consented in clinic or pre-op.\n\nAll procedures, devices, and ancillary equipment are standard of care. There is no additional cost to the patient, only the typical standard of care costs. Participants will not be compensated for participation in the study.', 'interventionNames': ['Device: Ureteroscopy using the 6.3 Fr f-URS hugemed', 'Device: Hugemed 6.3 Fr f-URS']}], 'interventions': [{'name': 'Ureteroscopy using the 6.3 Fr f-URS hugemed', 'type': 'DEVICE', 'description': "All patients will be counseled on standard treatment options. Treatment options and subsequent care will not deviate from routine care. If they do not enroll in the study, the HU30M may still be used during routine surgery and care. The only intervention specific to the research will involve the use of patient information in describing the results. Participants will undergo RIRS in standard fashion, without deviation from the standard of care. Patients will be brought to the operating room, positioned, and placed under general anesthesia. RIRS will be performed using HU30M 6.3 Fr f-URS. Laser platform (ex: HoYAG or TFL) as well as laser settings will be at the treating investigator's discretion and may be changed during the procedure at their discretion as well, all per standard of care. The initial laser settings and changes that occurred to the settings after the first minute of the case will be recorded.", 'armGroupLabels': ['hugemed ureteroscopy']}, {'name': 'Hugemed 6.3 Fr f-URS', 'type': 'DEVICE', 'description': 'Retrograde intrarenal surgery will be performed using HU30M 6.3 Fr f-URS.', 'armGroupLabels': ['hugemed ureteroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160-8500', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Jane Ledesma, manager', 'role': 'CONTACT', 'email': 'jledesma@kumc.edu', 'phone': '402-276-6857'}], 'facility': 'University Of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Wilson R. Molina, Md', 'role': 'CONTACT', 'email': 'wmolina@kumc.edu', 'phone': '+13037630909'}, {'name': 'Briston B. Whiles, md', 'role': 'CONTACT', 'email': 'bwhiles@kumc.edu', 'phone': '+18167693266'}], 'overallOfficials': [{'name': 'Wilson R. Molina, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data will be used to compare different outcomes from ureteroscopy surgeries'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}