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Sponsor study identifier
interventional
100
1 country
1
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
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Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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). Optional treatments of children with VUR include conservative therapy with or without prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery. In 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. In 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has become the treatment of choice in VUR grades 2-4. In 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). One 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. In 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). The aim of the current study is to compare the rate of resolution of the VUR using Deflux versus Vantris in bilateral VUR
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
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August 15, 2013
Actual (reported)October 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 22, 2014
Actual (reported)October 2015
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December 2015
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rate of resolution of VUR using Vantris vs.Deflux
2 years
In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.
Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.
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
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
Schneider Medical Center of Israel
Petah Tikva, Israel, Israel
David Ben-Meir, MD
Investigator
First Submitted
August 15, 2013
First Posted
October 22, 2014
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
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Study Completion
December 2015
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Last Updated
October 22, 2014
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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