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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks from completion of the study.
Awards & highlights
Study Summary
This trial aims to test how well Caption LungAI can detect lung cancer from images.
Who is the study for?
This trial is for adults over 18 who come to the hospital or outpatient clinics with shortness of breath and suspected B-lines, which are signs on a lung ultrasound that may indicate fluid in the lungs. It's not for patients in critical condition where an ultrasound isn't a priority.Check my eligibility
What is being tested?
The study is testing Caption LungAI, a type of artificial intelligence designed to help doctors interpret lung ultrasounds more effectively when evaluating patients with shortness of breath.See study design
What are the potential side effects?
Since Caption LungAI is a diagnostic tool rather than a medication or invasive procedure, it doesn't have direct side effects like drugs do. However, there could be indirect consequences if it incorrectly interprets lung scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks from completion of the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks from completion of the study.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
B-Line Significance
B-Lines Detection
Diagnostic Image Quality (Trained Healthcare Professional)
+1 moreSecondary outcome measures
Sub-group Analyses
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients presenting with clinical suspicion of B-LinesExperimental Treatment1 Intervention
Patients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes.
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Who is running the clinical trial?
Caption Health, Inc.Lead Sponsor
3 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are experiencing difficulty breathing and have suspected B-lines.You must be 18 years old or older.Patients who are in critical condition or have other urgent medical needs that would make it difficult to perform a research lung ultrasound.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Patients presenting with clinical suspicion of B-Lines
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial recruiting participants?
"Affirmative. Clinicaltrials.gov verifies that this experiment is actively seeking participants, with a first posting on July 17th 2023 and most recent alteration on August 7th 2023. The trial requires 220 subjects to be gathered from 4 distinct sites."
Answered by AI
Are there any available openings for participants in this research?
"Affirmative. Per the information provided on clinicaltrials.gov, this trial is actively seeking subjects - opening up recruitment opportunities on July 17th 2023 and most recently updated in August 7th 2023. 220 participants are required to be sourced from 4 distinct sites."
Answered by AI
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