Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02271035
Status:
UNKNOWN
Last Update Posted:
2014-10-22
First Post:
2013-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014718', 'term': 'Vesico-Ureteral Reflux'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder 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': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C094535', 'term': 'deflux'}, {'id': 'C013471', 'term': 'dextranomer'}, {'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'C530415', 'term': 'Vantris'}, {'id': 'C000656507', 'term': 'polyacrylate polyalcohol copolymer'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2014-10-21', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of resolution of VUR using Vantris vs.Deflux', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VUR'], 'conditions': ['Vesico-Ureteral Reflux']}, 'descriptionModule': {'briefSummary': 'Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at 1% of newborns, and 30-45% of the children who present with urinary tract infection (1).\n\nOptional treatments of children with VUR include conservative therapy with or without prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.\n\nIn an endoscopic technique, the injecting needle is inserted through the working channel of the cystoscope. The procedure is relatively short and is performed as out-patient surgery.\n\nIn 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has become the treatment of choice in VUR grades 2-4.\n\nIn 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT involves the use of a pressurized stream of fluid directed into the ureter to aid visualization, and injection into the submucosa within the ureteric tunnel to improve coaptation of the ureter (3).\n\nOne of the disadvantages attributed to Deflux is the loss of 20% of the injected material over time (a result of absorption of the hyaluronic acid), which may explain the lower success rate of the endoscopic treatment of VUR compared with open surgery.\n\nIn 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by preventing volume loss. Preliminary results of a three year follow-up using Vantris have shown high a level of reflux resolution(4).\n\nThe aim of the current study is to compare the rate of resolution of the VUR using Deflux versus Vantris in bilateral VUR', 'detailedDescription': "Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at 1% of newborns, and 30-45% of the children who present with urinary tract infection (1).\n\nOptional treatments of children with VUR include conservative therapy with or without prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.\n\nThe first endoscopic treatment was presented in 1981 by Matouschek, who injected Teflon into the submucosa of the ureteral orifice, at the six o'clock position (STING). In this technique, the injecting needle is inserted through the working channel of the cystoscope. The procedure is relatively short and is performed as out-patient surgery.\n\nIn 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has become the treatment of choice in VUR grades 2-4.\n\nIn 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT involves the use of a pressurized stream of fluid directed into the ureter to aid visualization, and injection into the submucosa within the ureteric tunnel to improve coaptation of the ureter (3).\n\nA review of Deflux therapy for VUR in 63 studies, including 8101 ureters, found a success rate of 51%-79% depending on VUR grade. (grade 1,2 79%, grade 3 72%, grade 4 63%, grade 5 51%) (2).\n\nOne of the disadvantages attributed to Deflux is the loss of 20% of the injected material over time (a result of absorption of the hyaluronic acid), which may explain the lower success rate of the endoscopic treatment of VUR compared with open surgery.\n\nIn 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by preventing volume loss. Preliminary results of a three year follow-up using Vantris have shown high a level of reflux resolution(4).\n\nThe aim of the current study is to compare the rate of resolution of the VUR using Deflux versus Vantris in bilateral VUR"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral VUR of the same grade\n\nExclusion Criteria:\n\n* Inability to apply the same technique on both ureteral orifices'}, 'identificationModule': {'nctId': 'NCT02271035', 'briefTitle': 'A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'A Prospective Study Comparing the Success Rate of Injection of Dextranomer /Hyaluronic Acid (DefluxR) Versus Polyacrylate Polyalcohol (VantrisR) for Treatment of Bilateral Similar Grade Vesicoureteral Reflux in Children', 'orgStudyIdInfo': {'id': 'Rabin Medical Center'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Deflux', 'description': 'In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.', 'interventionNames': ['Drug: Deflux']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vantris', 'description': 'Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.', 'interventionNames': ['Drug: Vantris']}], 'interventions': [{'name': 'Deflux', 'type': 'DRUG', 'otherNames': ['Dextranomer/hyaluronic acid'], 'description': 'Deflux will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one ureteral orifice and Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING', 'armGroupLabels': ['Deflux']}, {'name': 'Vantris', 'type': 'DRUG', 'otherNames': ['Polyacrylate Polyalcohol copolymer'], 'description': 'vantris will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING', 'armGroupLabels': ['Vantris']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David Ben-Meir, MD', 'role': 'CONTACT', 'email': 'davidbm@clalit.org.il', 'phone': '97239253347'}, {'name': 'David Ben-Meir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Schneider Medical Center of Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'David Ben-Meir, MD', 'role': 'CONTACT', 'email': 'davidbm@clalit.org.il', 'phone': '97239253118'}], 'overallOfficials': [{'name': 'David Ben-Meir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}