Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06824402
Status:
RECRUITING
Last Update Posted:
2025-04-21
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2025-04
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 goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:
Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?
How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?
Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?
Which collection method has the least amount of procedural time?
Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.
Participants will:
Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.
Assessed for any adverse events following the biopsy for up to 30 days after transplant.
Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?
How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?
Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?
Which collection method has the least amount of procedural time?
Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.
Participants will:
Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.
Assessed for any adverse events following the biopsy for up to 30 days after transplant.
Detailed Description:
The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: