Kidney Function in Patients With Bladder Exstrophy | NCT02192801

Studies
Kidney Function in Patients With Bladder Exstrophy

NCT02192801

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jul 17, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Classic Bladder Exstrophy
Renal Function
GFR
Proteinuria

Interventions

Not provided

Countries

Israel

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Not provided

First Submitted Date

Jan 30, 2014

First Submission Date that Met QC Criteria

Jul 16, 2014

First Posted Date

Jul 17, 2014Estimated

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

Jul 16, 2014

Last Update Posted Date

Jul 17, 2014Estimated

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

Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.

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

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal function	Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan	1 day (last visit )

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Patients with calssic bladder exstrophy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roxana Cleper, MD	Contact	972-3-6972512		roxanac@tlvmc.gov.il
Jacob Ben Chaim, MD	Contact			jacobbc@tlvmc.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D011507	Proteinuria

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided