Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-28 @ 6:52 PM
Study NCT ID:
NCT06547632
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}], '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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'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': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone Free Status between ClearPetra and traditional approach', 'timeFrame': '90 days', 'description': 'Stone free is defined as no residual stones \\>2mm in post operative CT scan'}], 'secondaryOutcomes': [{'measure': 'Total operative time between ClearPetra and traditional approach', 'timeFrame': '1 day', 'description': 'Time from scope insertion to scope removal from the patient'}, {'measure': 'Urinary tract infection between ClearPetra and traditional approach', 'timeFrame': '30 days of procedure', 'description': 'Data collection searching for urine tract infection signs, symptoms, antibiotic administration and culture'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Nephrolithiasis', 'Kidney Stone', 'ClearPetra', 'Ureteral access sheath'], 'conditions': ['Nephrolithiasis', 'Kidney Stone']}, 'referencesModule': {'references': [{'pmid': '30259124', 'type': 'BACKGROUND', 'citation': 'Tonyali S. Suctioning ureteral access sheath use in flexible ureteroscopy might decrease operation time and prevent infectious complications. World J Urol. 2019 Feb;37(2):393-394. doi: 10.1007/s00345-018-2510-5. Epub 2018 Sep 26. No abstract available.'}, {'pmid': '27238616', 'type': 'BACKGROUND', 'citation': 'Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.'}, {'pmid': '35986898', 'type': 'BACKGROUND', 'citation': 'Chen Y, Zheng L, Lin L, Li C, Gao L, Ke L, Kuang R, Chen J. A novel flexible vacuum-assisted ureteric access sheath in retrograde intrarenal surgery. BJU Int. 2022 Nov;130(5):586-588. doi: 10.1111/bju.15873. Epub 2022 Sep 6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure.\n\nRecently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration.\n\nBecause there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.', 'detailedDescription': 'Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration.\n\nThe new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females over18 years of age\n2. Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery\n3. Total stone burden between 1.0 to 2.5 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\n8. Non-elective procedures'}, 'identificationModule': {'nctId': 'NCT06547632', 'acronym': 'VA-UAS vs trad', 'briefTitle': 'ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach in Retrograde Intrarenal Surgery. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00161273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH', 'description': 'In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath.\n\nParticipants will undergo RIRS per standard of care.', 'interventionNames': ['Device: ClearPetra Ureteral access sheath']}, {'type': 'NO_INTERVENTION', 'label': '2. RIRS WITH TRADITIONAL APPROACH', 'description': 'In Arm 2, participants will undergo RIRS a traditional approach (no sheath or non-vacuum-assisted sheath). The treating investigator will decide whether to use a regular UAS based on their preference and/or availability.\n\n* No ureteral access sheath\n* Navigator™ Ureteral Access Sheath 11/13 Fr (Boston Scientific®)\n* Navigator™ Ureteral Access Sheath 12/14 Fr (Boston Scientific®)'}], 'interventions': [{'name': 'ClearPetra Ureteral access sheath', 'type': 'DEVICE', 'description': 'Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.', 'armGroupLabels': ['1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH']}]}, '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': 'Wilson Molina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Wilson Molina', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}