Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:57 AM
Study NCT ID:
NCT05708794
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjust-Unlikely PE
Sponsor:
Dr. Kerstin de Wit
Organization:
Study Overview
Official Title:
A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.
The pilot study objectives are to:
1. Determine study recruitment rate, per site, per month
2. Determine study 90-day loss to follow up rate
3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. Estimate of the Adjust-Unlikely algorithm efficiency
5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.
The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.
The pilot study objectives are to:
1. Determine study recruitment rate, per site, per month
2. Determine study 90-day loss to follow up rate
3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. Estimate of the Adjust-Unlikely algorithm efficiency
5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.
The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: