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COMPLETED Early Phase 1

Digestive Endoscopy Suite Radiation Controlling Protective Strategies

NCT02063841 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 2 participants
Start Date 2013-08
Est. Completion 2013-11
Phase Early Phase 1

Sponsor

Yale University

1,283 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02063841

The ClinicalTrials.gov registry entry for NCT02063841 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02063841 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02063841?

This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial