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NCT02204917 · ClinicalTrials.gov registry record · Phase 1
CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
A Phase 1 study of Vesicoureteral Reflux, sponsored by Kassa Darge.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT02204917: Completed Phase 1 study of Vesicoureteral Reflux, sponsored by Kassa Darge.
NCT02204917 is a Phase 1 study of Vesicoureteral Reflux that has completed, run by Kassa Darge. The registered enrollment target is 31 participants, below the 260-participant average among 3 other Vesicoureteral Reflux trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02204917, a Phase 1 study of Vesicoureteral Reflux, has completed, sponsored by Kassa Darge.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.
Primary Outcome
1. Presence or absence of vesicoureteral reflux identified by ceVUS and VCUG in each pelvic-ureter-unit (PUU) of each participant. PUU is an anatomic term that is used to describe the part of the urinary tract consisting of the renal calyces, pelvis and ureter. 2. Grading the severity of reflux detected by ceVUS and VCUG. Grade 0: absence of reflux. If reflux is present, a 5 grade scale (grades I-V) is used to evaluate its severity. Grade I: reflux in the ureter, grade II: reflux up to the renal
Conditions Studied
Interventions
- DRUG OPTISON
Study Locations (1)
Pennsylvania
- Department of Radiology, the Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
What the finished NCT02204917 record still lists
NCT02204917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 260-participant average among 3 other Vesicoureteral Reflux trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Vesicoureteral Reflux appearing as the primary indexed condition, and to 1 intervention - of which OPTISON is the first listed.
NCT02204917 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02204917 about?
NCT02204917 is a clinical study titled "CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children". In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.
What is the current status of trial NCT02204917?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-07. Estimated completion is 2017-03.
What conditions does trial NCT02204917 study?
This clinical trial studies the following conditions: Vesicoureteral Reflux.
What interventions are being tested in trial NCT02204917?
The interventions under investigation include: OPTISON (DRUG).
Who is sponsoring clinical trial NCT02204917?
This trial is sponsored by Kassa Darge, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02204917 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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