CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Intraoperative stereotactic imaging with VectorVisiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01878500
NCT01878500N/ACompleted
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Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI

Johns Hopkins University·interventional·Posted Jun 17, 2013·Updated Dec 21, 2021

In Brief

A clinical study evaluating Intraoperative stereotactic imaging with VectorVision for Bladder Exstrophy. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The aim of this study is to investigate the use of intraoperative stereotactic imaging of the pelvic floor musculature during closure of bladder exstrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Exstrophy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2013
Enrollment StartSep 1, 2012
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 13.0 years ago

Interventions

Intraoperative stereotactic imaging with VectorVisiondevice

Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.