Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01620658 · ClinicalTrials.gov registry record · NA
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
A NA study, sponsored by Baptist Health South Florida.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT01620658: Completed NA study, sponsored by Baptist Health South Florida.
NCT01620658 is a NA study that has completed, run by Baptist Health South Florida. The registered enrollment target is 197 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01620658, a NA study, has completed, sponsored by Baptist Health South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study Summary
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
Primary Outcome
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) e
Interventions
- DEVICE 0.5mm XPF cap
- DEVICE 0.3mm XPF cap
- DEVICE Standard cap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01620658 record still lists
NCT01620658 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which 0.5mm XPF cap is the first listed.
NCT01620658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01620658 about?
NCT01620658 is a clinical study titled "Radioprotective Light-weight Caps in the Interventional Cardiology Setting". The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided car...
What is the current status of trial NCT01620658?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2012-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01620658?
The interventions under investigation include: 0.5mm XPF cap (DEVICE), 0.3mm XPF cap (DEVICE), Standard cap (DEVICE).
Who is sponsoring clinical trial NCT01620658?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01620658's enrollment target sits among peer trials
197 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04219254 · 197 participants · Phase 1
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- NCT06173778 · 197 participants · Phase 2
Semaglutide for Post-Smoking Cessation Weight Management
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia