Radiation ExposureEarly Phase 1D-ERCPNCT02063841
Digestive Endoscopy Suite Radiation Controlling Protective Strategies
A Early Phase 1 study testing lead-free protective drape containing bismuth and antimony (RADPAD®) in people with Radiation Exposure, run by Yale University at 1 site in United States.
Trial summary
ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As… Read more about this study
- Who is it for?
- Ages 45 to 50 years
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- lead-free protective drape containing bismuth and antimony (RADPAD®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- Phase
- Early Phase 1
- 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 45 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All the ERCP procedures done by the same endoscopist and nurse are enrolled
- Patients age >19
Who cannot join
- Fluoroscopic procedures other than ERCP were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital
New Have, Connecticut, 06510
About this study
Official title: A Prospective Double-blind, Randomized, Sham-controlled Trial to Evaluate the Effect of a Lead Free Drape on Scatter Radiation Exposure to Endoscopy Staff During Endoscopic Retrograde Cholangiopancreatography
ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.
Read the detailed description
A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.
- Conditions
- Radiation Exposure
- Being tested
- lead-free protective drape containing bismuth and antimony (RADPAD®), sterile identical sham drape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lead-free protective drape containing bismuth and antimony (RADPAD®)Device
sterile identical sham drapeDevice
| Study group | Role | What they receive |
|---|---|---|
| sterile identical sham drape | Active comparator | Sham drape and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). Receives: Device: sterile identical sham drape |
| lead-free protective drape containing bismuth and antimony | Experimental | lead-free protective drape containing bismuth and antimony (RADPAD®) hung around the fluoroscopy image intensifier to prevent scatter radiation, and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). Receives: Device: lead-free protective drape containing bismuth and antimony (RADPAD®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of radiation exposure
Comparing the use of a lead-free protective drape containing bismuth and antimony and a sterile sham protective drape, radiation dose (RD) was measured at 3 different sites (endoscopist's eye (1) and thyroid (2), and assisting nurse's thyroid (3)) with personal dosimeters placed outside of eyeglass frames and the thyroid shield. The unit of measurement is each event. The subject was subjected to radiation during 100 Endoscopic retrograde cholangiopancreatography procedures.Both groups used standard of care lead protection.
Measured: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Secondary outcomes (1)
Estimate cumulative annual radiation risk
Comparing the use of a lead-free protective drape containing bismuth and antimony and a sterile sham protective drape, radiation dose (RD) was measured at 3 different sites (endoscopist's eye (1) and thyroid (2), and assisting nurse's thyroid (3)) with personal dosimeters placed outside of eyeglass frames and the thyroid shield. The unit of measurement is each event. The subject was subjected to radiation during 100 endoscopic retrograde cholangiopancreatography procedures. The cumulative estimated annual absorbed radiation dose was estimated from the data collected during the study time frame.
Measured: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priya Jamidar, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063841
- Sponsor's protocol ID
- 1210010994.Jamidar
- Acronym
- D-ERCP
- Status last verified
- Aug 2015
- First submitted
- 12 Feb 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-blind, Randomized, Sham-controlled Trial to Evaluate the Effect of a Lead Free Drape on Scatter Radiation Exposure to Endoscopy Staff During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02063841
- Acronym / sponsor ID
- D-ERCP / 1210010994.Jamidar
- Conditions
- Radiation Exposure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Feb 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.
ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.
Detailed description
A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sterile identical sham drape | Active comparator | Device: sterile identical sham drapeSham drape and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). |
| lead-free protective drape containing bismuth and antimony | Experimental | Device: lead-free protective drape containing bismuth and antimony (RADPAD®)lead-free protective drape containing bismuth and antimony (RADPAD®) hung around the fluoroscopy image intensifier to prevent scatter radiation, and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). |
Who may qualify
- Ages
- 45 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All the ERCP procedures done by the same endoscopist and nurse are enrolled
- Patients age >19
Key exclusion criteria (1 listed)
- Fluoroscopic procedures other than ERCP were excluded.
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 |
|---|---|---|
| lead-free protective drape containing bismuth and antimony (RADPAD®) | Device | lead-free protective drape containing bismuth and antimony |
| sterile identical sham drape | Device | sterile identical sham drape |
Primary outcome
Amount of radiation exposure
Time frame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Comparing the use of a lead-free protective drape containing bismuth and antimony and a sterile sham protective drape, radiation dose (RD) was measured at 3 different sites (endoscopist's eye (1) and thyroid (2), and assisting nurse's thyroid (3)) with personal dosimeters placed outside of eyeglass frames and the thyroid shield. The unit of measurement is each event. The subject was subjected to radiation during 100 Endoscopic retrograde cholangiopancreatography procedures.Both groups used standard of care lead protection.
1 secondary outcome
Estimate cumulative annual radiation risk
Time frame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
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 20 Aug 2015.
- A Double-Blind, Randomized, Sham-Controlled Trial of the Effect of a Radiation-Attenuating Drape on Radiation Exposure to Endoscopy Staff During ERCPLink provided by the sponsor.
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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.
Priya Jamidar, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing lead-free protective drape containing bismuth and antimony (RADPAD®) in people with Radiation Exposure, run by Yale University 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 1 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 20 Aug 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of radiation exposure (time frame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2015.