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NCT05059691 · ClinicalTrials.gov registry record
Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 5
- Enrollment target
NCT05059691: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT05059691 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05059691 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 5 participants
- Enrollment target
Study Summary
This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.
Primary Outcome
The proportion of patients developing pneumothorax will be compared with the proportion in the historical control (i.e., 20%) using two-sided binomial test. A p-value of less than 0.05 will indicate a statistical significance. The proportion of patients identified as developing pneumothorax and its exact 95% confidence interval will be estimated. Poisson regression model will be used to estimate the incidence of pneumothorax accounting for the number of biopsy sites.
Interventions
- OTHER Electronic Health Record Review
- PROCEDURE Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-03-30 |
| Est. Completion | 2023-05-11 |
What the finished NCT05059691 record still lists
NCT05059691 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Electronic Health Record Review is the first listed.
NCT05059691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05059691 about?
NCT05059691 is a clinical study titled "Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy". This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a complet...
What is the current status of trial NCT05059691?
This trial is currently completed. The enrollment target is 5 participants. The study started on 2021-03-30. Estimated completion is 2023-05-11.
What interventions are being tested in trial NCT05059691?
The interventions under investigation include: Electronic Health Record Review (OTHER), Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy (PROCEDURE).
Who is sponsoring clinical trial NCT05059691?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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