Gas Embolism With Use of Argon Plasma Coagulation
1 other identifier
observational
42
1 country
1
Brief Summary
The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2011
CompletedMarch 28, 2017
March 1, 2017
3 years
May 9, 2008
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of gas bubbles with use of APC
end of procedure
Eligibility Criteria
patients referred to tertiary care center
You may qualify if:
- Adults (male and female) 18 years of age or older
- Clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance)
- Ability of the patient or proxy to read, comprehend, and sign informed consent document.
You may not qualify if:
- Presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery)
- Presence of coagulopathy or other bleeding diathesis
- Inability to tolerate brief periods of apnea
- Presence of pulmonary vascular disease
- Pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adnan Majid, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
July 1, 2008
Primary Completion
July 5, 2011
Study Completion
July 5, 2011
Last Updated
March 28, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
IPD was not shared