Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT05894668
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Parameter and Treatment Outcomes of ECIRS in Asia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Stone status', 'timeFrame': 'up to 1 year', 'description': 'The fragmentation rate of target stone'}, {'measure': 'Treatment related complication', 'timeFrame': 'Thirty days after the operation', 'description': 'he 30-day complications will be graded according to the Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Stone']}, 'referencesModule': {'references': [{'pmid': '19060340', 'type': 'BACKGROUND', 'citation': 'Chan SW, Ng CF, Man CW, Chung R, Li SK. A report on a randomly sampled questionnaire survey about renal stone disease in Hong Kong. Hong Kong Med J. 2008 Dec;14(6):427-31.'}, {'pmid': '31016804', 'type': 'BACKGROUND', 'citation': 'Taguchi K, Cho SY, Ng AC, Usawachintachit M, Tan YK, Deng YL, Shen CH, Gyawali P, Alenezi H, Basiri A, Bou S, Djojodemedjo T, Sarica K, Shi L, Singam P, Singh SK, Yasui T. The Urological Association of Asia clinical guideline for urinary stone disease. Int J Urol. 2019 Jul;26(7):688-709. doi: 10.1111/iju.13957. Epub 2019 Apr 24.'}, {'pmid': '18715696', 'type': 'BACKGROUND', 'citation': 'Scoffone CM, Cracco CM, Cossu M, Grande S, Poggio M, Scarpa RM. Endoscopic combined intrarenal surgery in Galdakao-modified supine Valdivia position: a new standard for percutaneous nephrolithotomy? Eur Urol. 2008 Dec;54(6):1393-403. doi: 10.1016/j.eururo.2008.07.073. Epub 2008 Aug 8.'}, {'pmid': '22057344', 'type': 'BACKGROUND', 'citation': 'Cracco CM, Scoffone CM. ECIRS (Endoscopic Combined Intrarenal Surgery) in the Galdakao-modified supine Valdivia position: a new life for percutaneous surgery? World J Urol. 2011 Dec;29(6):821-7. doi: 10.1007/s00345-011-0790-0. Epub 2011 Nov 6.'}, {'pmid': '23987470', 'type': 'BACKGROUND', 'citation': 'Hamamoto S, Yasui T, Okada A, Taguchi K, Kawai N, Ando R, Mizuno K, Kubota Y, Kamiya H, Tozawa K, Kohri K. Endoscopic combined intrarenal surgery for large calculi: simultaneous use of flexible ureteroscopy and mini-percutaneous nephrolithotomy overcomes the disadvantageous of percutaneous nephrolithotomy monotherapy. J Endourol. 2014 Jan;28(1):28-33. doi: 10.1089/end.2013.0361. Epub 2013 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.', 'detailedDescription': 'Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with urinary stones and planned for ECIRS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with urinary calculi\n* Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS)\n* Agreed to consent for the study\n\nExclusion Criteria:\n\n* Patients who have ECIRS for other conditions, such as urothelial cancer etc.\n* Patients who intraoperative record was incomplete.\n* Patients only have either PCNL or ureteroscopy done (not both)'}, 'identificationModule': {'nctId': 'NCT05894668', 'briefTitle': 'Perioperative Parameter and Treatment Outcomes of ECIRS in Asia', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia', 'orgStudyIdInfo': {'id': 'CRE-2023.172'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECIRS', 'type': 'OTHER', 'description': 'Endoscopic Combined Intrarenal Surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu.hk', 'phone': '35052625'}], 'facility': 'Alice Ho Miu Ling Nethersole Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu.hk', 'phone': '3505 3953'}, {'name': 'Pui Tak LAI, BN', 'role': 'CONTACT', 'email': 'francolai@surgery.cuhk.edu.hk', 'phone': '3505 1663'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Sheung Shui', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu..hk', 'phone': '3505-2625'}], 'facility': 'North District Hospital', 'geoPoint': {'lat': 22.51667, 'lon': 114.11667}}], 'centralContacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu.hk', 'phone': '35052625'}], 'overallOfficials': [{'name': 'Chi Fai NG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi Fai NG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}