Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06795256
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Homework in Retrograde Intrarenal Surgery
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-25', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rates', 'timeFrame': '1 month after the intervention/procedure/surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery', 'timeFrame': '1 month after the intervention/procedure/surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retrograde Intrarenal Surgery', 'Stone, Kidney']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an indication for RIRC\n\nExclusion Criteria:\n\n* Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.\n* Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.\n* Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.'}, 'identificationModule': {'nctId': 'NCT06795256', 'briefTitle': 'Homework in Retrograde Intrarenal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University'}, 'officialTitle': 'Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery', 'orgStudyIdInfo': {'id': 'HRÜ/24.21.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery', 'interventionNames': ['Behavioral: Percussion and position change in retrograde intrarenal surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Retrograde Intrarenal Surgery'}], 'interventions': [{'name': 'Percussion and position change in retrograde intrarenal surgery', 'type': 'BEHAVIORAL', 'description': 'To evaluate the effectiveness of this homework on stone clearance rates after RIRC by giving instructions to the patient in the home environment and suggesting percussion (tapping) and movement/position changes to help spontaneous stone passage.', 'armGroupLabels': ['Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02400', 'city': 'Adıyaman', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ADIYAMAN EDUCATION AND RESEARCH HOSPITAL', 'role': 'CONTACT', 'email': 'adiyamaneah1@saglik.gov.tr', 'phone': '+90 416 216 10 15'}], 'facility': 'Adıyaman University', 'geoPoint': {'lat': 37.76441, 'lon': 38.27629}}], 'centralContacts': [{'name': 'Bedreddin Kalyenci, Doctor', 'role': 'CONTACT', 'email': 'bedreddin84@windowslive.com', 'phone': '+905554859583'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bedreddin Kalyenci', 'investigatorAffiliation': 'Adiyaman University'}}}}