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Digestive Endoscopy Suite Radiation Controlling Protective Strategies

NCT02063841 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-08-20

No results posted yet for this 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.

Conditions

  • Radiation Exposure

Interventions

DEVICE

lead-free protective drape containing bismuth and antimony (RADPAD®)

DEVICE

sterile identical sham drape

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Priya Jamidar, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063841 on ClinicalTrials.gov