Prospective Pediatric Vesicoureteral Reflux Surgery Database | NCT01373385

Studies
Prospective Pediatric Vesicoureteral Reflux Surgery Database

NCT01373385

Sponsor

Connecticut Children's Medical Center

Status

Completed

Last Update Posted

Jan 5, 2017Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Vesicoureteral Reflux

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jun 14, 2011

First Posted Date

Jun 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2017

Last Update Posted Date

Jan 5, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christina Kim, MD, Attending physician, Connecticut Children's Medical CenterPrincipal Investigator

Lead Sponsor

Connecticut Children's Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical		Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of vesicoureteral reflux	Resolution of vesicoureteral reflux	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Exclusion Criteria:

Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Kim, MD	Connecticut Children's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Connecticut Children's Medical Center		Hartford	Connecticut	06106	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014718	Vesico-Ureteral Reflux

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided