Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Primary Purpose
Vesico-Ureteral Reflux
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
endoscopic treatment of vesico-renal reflux
Sponsored by
About this trial
This is an interventional treatment trial for Vesico-Ureteral Reflux focused on measuring Vesico-ureteral reflux, autologous adipocytes, adipocytes graft
Eligibility Criteria
Inclusion criteria : sexe : male and female age : 3 to 15 years written consent Vesico-renal reflux staged I to III revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure. Exclusion criteria : Before 3 years or older than 15 years insulino-dépendant diabet neurologic bladder abnormalities of the urinary tract kidney transplantation past history of bladder surgery anorexia (BMI <12) Vesico-renal reflux staged IV or V Active urinary tract infection
Sites / Locations
- Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de StrasbourgRecruiting
Outcomes
Primary Outcome Measures
Realization of an urethrocystography
Secondary Outcome Measures
Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years)
Full Information
NCT ID
NCT00367159
First Posted
August 21, 2006
Last Updated
February 24, 2009
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00367159
Brief Title
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Official Title
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively, medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive and not free of complication. Medical treatment is submissive to a good observance. The introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR elimination. Since the beginning of the endoscopic treatment, several bulking agents have been proposed. The ideal agent should be easy to inject, stable in time and should be safe. Of course it should be at least as efficient as actual bulking agent. The use of Teflon was the first wave of success of endoscopic treatment. But sudden passion of Teflon has been darkened by the notion of migration. Since, others substances have been proposed, autologous or exogenous, resorbable or not. But none was ideal and no solutions were found facing problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with Coleman who introduced a new technique called "lipostructure". This technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft. We propose to apply this technique to VRR management in children in order to combine innocuousness and efficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesico-Ureteral Reflux
Keywords
Vesico-ureteral reflux, autologous adipocytes, adipocytes graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
endoscopic treatment of vesico-renal reflux
Intervention Description
Autologous Adipocytes Graft (lipostructure)
Primary Outcome Measure Information:
Title
Realization of an urethrocystography
Time Frame
at 3 months and 1 year
Secondary Outcome Measure Information:
Title
Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years)
Time Frame
Day 1; Month 1; Month 3 ; Year 1; Year 5 and Year 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
sexe : male and female
age : 3 to 15 years
written consent
Vesico-renal reflux staged I to III revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure.
Exclusion criteria :
Before 3 years or older than 15 years
insulino-dépendant diabet
neurologic bladder
abnormalities of the urinary tract
kidney transplantation
past history of bladder surgery
anorexia (BMI <12)
Vesico-renal reflux staged IV or V
Active urinary tract infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François BECMEUR, MD
Phone
33.3.88.12.73.13
Email
francois.becmeur@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BECMEUR, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BECMEUR, MD
Phone
33.3.88.12.73.13
Email
francois.becmeur@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Francois BECMEUR, MD
First Name & Middle Initial & Last Name & Degree
Raphaël MOOG, MD
First Name & Middle Initial & Last Name & Degree
Isabelle KAUFFMANN, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
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