Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT07020520
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'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': 'There is a main study and pharmacokinetic (PK) substudy. All subjects will receive the same treatment. PK substudy subjects (15) will also have serum and urine samples collected for analysis of paclitaxel levels.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful treatment', 'timeFrame': '6-months post ureteral stent removal (approximately 7 months post Optilume treatment)', 'description': 'Rate of successful treatment defined as meeting all the following criteria:\n\n* Technical success\n* Freedom from retreatment of target stricture through six months post stent removal\n* Renogram at 6 months showing stability or improvement in split function for impacted kidney defined as split function within 10% of baseline value or improved from baseline.\n* T1/2 stability or improvement from baseline to 6 months for impacted kidney'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ureteral', 'ureteric', 'stricture', 'stenosis', 'optilume'], 'conditions': ['Ureteral Stricture']}, 'descriptionModule': {'briefSummary': 'The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length\n3. Two functioning kidneys\n\nExclusion Criteria:\n\n1. Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment\n2. Subjects with more than one ureteric stricture\n3. Subjects with target stricture in bifid or duplicated ureter\n4. Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel\n5. Ureteric stricture caused by extrinsic compression of the ureter\n6. Unable to endoscopically access target stricture for any reason\n7. Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture\n8. Chronic renal failure treated with dialysis\n9. eGFR \\<30 mL/min/1.73m2\n10. Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram\n11. Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function\n12. Life expectancy less than 12 months\n13. Women who are pregnant or breastfeeding\n14. Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months\n15. Males unwilling to abstain or use protected sex for 30 days post treatment\n16. Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential\n17. Inability to provide legally effective informed consent\n18. Unwilling or unable to meet protocol follow-up requirements\n19. Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial\n20. Active systemic or urinary tract infection\n21. Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months\n22. Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline\n23. Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator\n24. Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure\n25. Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response\n26. Presence of any condition that precludes administration of furosemide during renograms\n27. Unable to tolerate contrast related to required study procedures or imaging.\n\nAdditional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications'}, 'identificationModule': {'nctId': 'NCT07020520', 'acronym': 'ENDURE1', 'briefTitle': 'EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Urotronic Inc.'}, 'officialTitle': 'EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures', 'orgStudyIdInfo': {'id': '1391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optilume', 'description': 'Treatment with Optilume for ureteric stricture', 'interventionNames': ['Device: Optilume']}], 'interventions': [{'name': 'Optilume', 'type': 'DEVICE', 'description': 'Has pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.', 'armGroupLabels': ['Optilume']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaime Landman, MD', 'role': 'CONTACT', 'email': 'landmanj@hs.uci.edu', 'phone': '9498249320'}, {'name': 'Jaime Landman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucas Wiegand, MD', 'role': 'CONTACT', 'email': 'lucas.wiegand@orlandohealth.com', 'phone': '877-876-3627'}, {'name': 'Lucas Wiegand, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Palese, MD', 'role': 'CONTACT', 'email': 'michael.palese@mountsinai.org', 'phone': '212-844-8900'}, {'name': 'Michael Palese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maia VanDyke, MD', 'role': 'CONTACT', 'email': 'maiavandyke@utsouthwestern.edu', 'phone': '214-645-8765'}, {'name': 'Maia VanDyke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin McCormick, MD', 'role': 'CONTACT', 'email': 'benjamin.mccormick@hsc.utah.edu', 'phone': '801-213-2718'}, {'name': 'Benjamin McCormick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Steven M Principal Clinical Project Manager', 'role': 'CONTACT', 'email': 'smadej@laborie.com', 'phone': '952-426-6079'}, {'name': 'Reem Ennenga', 'role': 'CONTACT', 'email': 'rennenga@laborie.com'}], 'overallOfficials': [{'name': 'Jamie Landman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urotronic Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Laborie Medical Technologies Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}