Trial · NCT02204917
CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
NCT02204917, Phase 1, Phase 2, Completed, Kassa Darge; results first posted 2018-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children. Trials, record NCT02204917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02204917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
- NCT number
- NCT02204917
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Kassa Darge
- Conditions
- Vesico-Ureteral Reflux
- Interventions
- OPTISON
- First posted
- 2014-07-31
- Last updated
- 2018-11-27
- Results first posted
- 2018-11-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | 10-15 minutes. | 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 pelvis, grade III: reflux up to the renal pelvis with mild dilation of the ureter and pelvicalyceal system, grade IV reflux up to the renal pelvis with moderate dilation but preserved papillary impressions, grade V: reflux up to the renal pelvis with severe dilation and loss of papillary impressions. Higher grades of reflux are associated with increased risk of urinary tract infection. 3. Imaging of the urethra during voiding (urethra visualized or not) and urethra pathology detection. |
| Primary | Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG). | Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion. | The overall safety and tolerability of ceVUS with OPTISON was assessed before, during and immediately after each ceVUS and VCUG examinations, and in follow-up telephone interviews. Assessments included: 1. evaluation of body systems for signs of generalized hypersensitivity, allergic or anaphylactoid reactions 2. monitoring of heart rate and pulse oxygen saturation 3. telephone questionnaire-based interview of parents/guardians and children 48 hours after the examinations for delayed adverse events. The severity of any possible adverse event was classified as mild, moderate or serious and the onset of symptoms was categorized as acute, subacute or delayed according to the World Health Organization (WHO) classifications. In addition, the adverse event was classified as anticipated if it was expected given the study related procedures or unanticipated if the subject was exposed to greater risk than previously known or recognized. |
| Secondary | Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children. | 10-15 minutes. | The diagnostic accuracy of ceVUS will be assessed by evaluation of the true positive, true negative, false positive and false negative cases of reflux and urethral imaging findings detected by ceVUS and VCUG examinations. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | 10-15 minutes. | In total, 59 kidneys with 62 pelvic-ureteric units (PUUs) in 30 children were analyzed. | pelvic-ureteric units (PUUs) | NUMBER |
| PRIMARY | Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG). | Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion. | participants | NUMBER | |
| SECONDARY | Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children. | 10-15 minutes. | Voiding Cysteourethrography (VCUG) is used as the reference standard the results for ceVUS. | percentage | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With ceVUS | Grade 0 reflux | 50 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With VCUG | Grade 0 reflux | 50 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With ceVUS | Grade I reflux | 2 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With VCUG | Grade I reflux | 2 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With ceVUS | Grade II reflux | 8 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With VCUG | Grade II reflux | 6 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With ceVUS | Grade III reflux | 2 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With VCUG | Grade III reflux | 4 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With ceVUS | Grade IV reflux | 0 | pelvic-ureteric units (PUUs) | |
| Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). | Severity of Reflux With VCUG | Grade IV reflux | 0 | pelvic-ureteric units (PUUs) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ceVUS With the Use of OPTISON & VCUG in the Same Session | 31 | |
| Overall Study | COMPLETED | ceVUS With the Use of OPTISON & VCUG in the Same Session | 30 | |
| Overall Study | NOT COMPLETED | ceVUS With the Use of OPTISON & VCUG in the Same Session | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysuria | Renal and urinary disorders | ceVUS With the Use of OPTISON & VCUG in the Same Session | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ceVUS With the Use of OPTISON & VCUG in the Same Session | 0 | 30 |
| Total, other adverse events | ceVUS With the Use of OPTISON & VCUG in the Same Session | 1 | 30 |
| Total, serious adverse events | ceVUS With the Use of OPTISON & VCUG in the Same Session | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02204917
GET https://conductscience.org/api/trials/v1/NCT02204917/registered