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NCT02063841 · ClinicalTrials.gov registry record · Early Phase 1
Digestive Endoscopy Suite Radiation Controlling Protective Strategies
A Early Phase 1 study of Radiation Exposure, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT02063841: Completed Early Phase 1 study of Radiation Exposure, sponsored by Yale University.
NCT02063841 is a Early Phase 1 study of Radiation Exposure that has completed, run by Yale University. The registered enrollment target is 2 participants, below the 50-participant average among 7 other Radiation Exposure trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02063841, a Early Phase 1 study of Radiation Exposure, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study 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 Low As Reasonably Achievable) principle.
Primary Outcome
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 stand
Conditions Studied
Interventions
- DEVICE lead-free protective drape containing bismuth and antimony (RADPAD®)
- DEVICE sterile identical sham drape
Study Locations (1)
Connecticut
- Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital - New Have
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-11 |
| Phase | Early Phase 1 |
What the finished NCT02063841 record still lists
NCT02063841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 50-participant average among 7 other Radiation Exposure trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Radiation Exposure appearing as the primary indexed condition, and to 2 interventions - of which lead-free protective drape containing bismuth and antimony (RADPAD®) is the first listed.
NCT02063841 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT02063841 about?
NCT02063841 is a clinical study titled "Digestive Endoscopy Suite Radiation Controlling Protective Strategies". 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...
What is the current status of trial NCT02063841?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2013-08. Estimated completion is 2013-11.
What conditions does trial NCT02063841 study?
This clinical trial studies the following conditions: Radiation Exposure.
What interventions are being tested in trial NCT02063841?
The interventions under investigation include: lead-free protective drape containing bismuth and antimony (RADPAD®) (DEVICE), sterile identical sham drape (DEVICE).
Who is sponsoring clinical trial NCT02063841?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02063841 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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