UrolithiasisNCT02224287
Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control
A study of Urolithiasis and Kidney Stones, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Urolithiasis, Kidney Stones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing ureteroscopy for urolithiasis
- 5 years to 25 years old
Who cannot join
- Pregnant
- Less than 5 years old or older than 25 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial
This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD.
It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.
- Conditions
- Urolithiasis, Kidney Stones
- Being tested
- Technologist control of fluoroscopy, Surgeon control of fluoroscopy
- Keywords
- Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technologist control of fluoroscopyProcedure or surgery
Technologist control of fluoroscopy
Surgeon control of fluoroscopyProcedure or surgery
Surgeon control of fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy | Other | Technologist control of fluoroscopy Surgeon control of fluoroscopy Receives: Procedure: Technologist control of fluoroscopy; Procedure: Surgeon control of fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome in this study will be total fluoroscopy time for the procedure.
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
Measured: 1-5 hours
Secondary outcomes (1)
A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
Measured: 1-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caleb Nelson, Boston Children's Hospital
- Investigators
- Caleb Nelson, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224287
- Sponsor's protocol ID
- P00003145
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2014
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kokorowski PJ, Chow JS, Cilento BG Jr, Kim DS, Kurtz MP, Logvinenko T, MacDougall RD, Nelson CP. The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial. J Pediatr Urol. 2018 Aug;14(4):334.e1-334.e8. doi: 10.1016/j.jpurol.2018.04.035. Epub 2018 Jun 27.
PubMed 30257794
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02224287
- Acronym / sponsor ID
- P00003145
- Conditions
- Urolithiasis, Kidney Stones
- Keywords
- Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD.
It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy | Other | Procedure: Technologist control of fluoroscopy, Procedure: Surgeon control of fluoroscopyTechnologist control of fluoroscopy Surgeon control of fluoroscopy |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients undergoing ureteroscopy for urolithiasis
- 5 years to 25 years old
Key exclusion criteria (2 listed)
- Pregnant
- Less than 5 years old or older than 25 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technologist control of fluoroscopyTechnologist control of fluoroscopy | Procedure or surgery | Fluoroscopy |
| Surgeon control of fluoroscopySurgeon control of fluoroscopy | Procedure or surgery | Fluoroscopy |
Primary outcome
The primary outcome in this study will be total fluoroscopy time for the procedure.
Time frame: 1-5 hours
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
1 secondary outcome
A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.
Time frame: 1-5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 30257794Kokorowski PJ, Chow JS, Cilento BG Jr, Kim DS, Kurtz MP, Logvinenko T, MacDougall RD, Nelson CP. The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial. J Pediatr Urol. 2018 Aug;14(4):334.e1-334.e8. doi: 10.1016/j.jpurol.2018.04.035. Epub 2018 Jun 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caleb Nelson, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Urolithiasis and Kidney Stones, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome in this study will be total fluoroscopy time for the procedure. (time frame: 1-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.