Vesico-Ureteral RefluxPhase 3NCT00367159
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
A Phase 3 study testing endoscopic treatment of vesico-renal reflux in people with Vesico-Ureteral Reflux, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Vesico-Ureteral Reflux
- What is being tested?
- endoscopic treatment of vesico-renal reflux
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- anorexia (BMI <12)
- Vesico-renal reflux staged IV or V
- Active urinary tract infection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
François BECMEUR, MD, 33.3.88.12.73.13, francois.becmeur@chru-strasbourg.fr
Francois BECMEUR, MD
About this study
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.
- Conditions
- Vesico-Ureteral Reflux
- Being tested
- endoscopic treatment of vesico-renal reflux
- Keywords
- Vesico-ureteral reflux, autologous adipocytes, adipocytes graft
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic treatment of vesico-renal refluxProcedure or surgery
Autologous Adipocytes Graft (lipostructure)
What is being measured
The primary outcome is the main question the study is designed to answer.
Realization of an urethrocystography
Measured: at 3 months and 1 year
Secondary outcomes (1)
Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years)
Measured: Day 1; Month 1; Month 3 ; Year 1; Year 5 and Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesico-Ureteral RefluxStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- François BECMEUR, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367159
- Sponsor's protocol ID
- 3490
- Other IDs
- TC 197
- Status last verified
- Feb 2009
- First submitted
- 21 Aug 2006
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
- ClinicalTrials.gov ID
- NCT00367159
- Acronym / sponsor ID
- 3490
- Conditions
- Vesico-Ureteral Reflux
- Keywords
- Vesico-ureteral reflux, autologous adipocytes, adipocytes graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Before 3 years or older than 15 years
- insulino-dépendant diabet
- neurologic bladder
- abnormalities of the urinary tract
- kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic treatment of vesico-renal refluxAutologous Adipocytes Graft (lipostructure) | Procedure or surgery | – |
Primary outcome
Realization of an urethrocystography
Time frame: at 3 months and 1 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François BECMEUR, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endoscopic treatment of vesico-renal reflux in people with Vesico-Ureteral Reflux, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François BECMEUR, MD (33.3.88.12.73.13, francois.becmeur@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realization of an urethrocystography (time frame: at 3 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009.