CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Bridge Balloondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02714153
NCT02714153N/ACompleted
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Bridge Occlusion Balloon Initial Use in Humans Study

Yale University·interventional·Posted Mar 21, 2016·Updated Jun 14, 2021

In Brief

A clinical study evaluating Bridge Balloon for C.Surgical Procedure; Cardiac and 2 related conditions. Completed, enrolled 23 participants across 7 sites.

Detailed Summary

To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsC.Surgical Procedure; Cardiac, Cardiac Dysrhythmia, Disorder of Pacing Function
CountriesUnited States
CollaboratorsSpectranetics Corporation

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 21, 2016
Enrollment StartApr 1, 2016
Primary CompletionMay 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.3 years ago

Interventions

Bridge Balloondevice

The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy.