Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722340
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-01-18
Brief Title:
NIVATS Versus IGAVATS a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Video-assisted Thoracic Surgery for Lung Biopsy Using Non-intubated NIVATS Versus Intubated General Anaesthesia IGAVATS a Randomized Controlled Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Status:
RECRUITING
Status Verified Date:
2023-06
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:
NIVATS-2
Brief Summary:
The main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease ILD in terms of diagnostic confidence as determined by histologists
Detailed Description:
The primary objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease ILD in terms of diagnostic confidence as determined by histologists The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery NIVATS technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery IGAVATS technique
Secondarily the two groups will also be compared in terms of i further variables associated with histology biopsy quality and size ii surgical performance iii patient trajectories and lung function iv quality of life and v harms
Secondarily the two groups will also be compared in terms of i further variables associated with histology biopsy quality and size ii surgical performance iii patient trajectories and lung function iv quality of life and v harms
Study Oversight
Has Oversight DMC:
None
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?:
None