Vesicoureteral RefluxNCT01373385
Prospective Pediatric Vesicoureteral Reflux Surgery Database
An observational study of Vesicoureteral Reflux, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Vesicoureteral Reflux
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2016
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.
Who may be able to join
- Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
Who cannot join
- Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux.
Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures.
Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.
- Conditions
- Vesicoureteral Reflux
- Keywords
- pediatric urology, vesicoureteral reflux, ureteral reimplant, Deflux
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of vesicoureteral reflux
Resolution of vesicoureteral reflux
Measured: Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kim, MD, Connecticut Children's Medical Center
- Investigators
- Christina Kim, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373385
- Sponsor's protocol ID
- 10-049
- Status last verified
- Jan 2017
- First submitted
- 14 Jul 2010
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pediatric Vesicoureteral Reflux Surgery Database
- ClinicalTrials.gov ID
- NCT01373385
- Acronym / sponsor ID
- 10-049
- Conditions
- Vesicoureteral Reflux
- Keywords
- pediatric urology, vesicoureteral reflux, ureteral reimplant, Deflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jun 2011 (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.
The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux.
Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures.
Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.
Key inclusion criteria (1 listed)
- Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
Key exclusion criteria (1 listed)
- Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resolution of vesicoureteral reflux
Time frame: Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday.
Resolution of vesicoureteral reflux
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Christina Kim, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vesicoureteral Reflux, run by Connecticut Children's Medical Center at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2017. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of vesicoureteral reflux (time frame: Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday.). 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 5 Jan 2017.