Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 12:05 AM
Study NCT ID:
NCT02271035
Status:
UNKNOWN
Last Update Posted:
2014-10-22
First Post:
2013-08-15
Is NOT 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:
Rabin Medical Center
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2014-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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.
The 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.
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).
A 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).
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
Optional treatments of children with VUR include conservative therapy with or without prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.
The 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.
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).
A 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).
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: