Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298604
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-01
Brief Title:
Motorized Fine Needle Biopsy vs Standard Needles
Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Organization:
Instituto Ecuatoriano de Enfermedades Digestivas
Study Overview
Official Title:
Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy FNB With Standard Needle for Pancreatic and Liver Biopsies
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy A newly developed motorized fine needle biopsy mFNB the Precision-GI Limaca Israel promises intact tissue acquisition without sample damage relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition
Given the advancement mentioned the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound EUS-guided pancreatic and liver specimens through a prospective interventional single-center trial The study will consist of two groups of patients one assigned to the standard fine needle biopsy FNB and the other to the mFNB The primary study outcomes will include sample quality core integrity and diagnostic accuracy
Given the advancement mentioned the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound EUS-guided pancreatic and liver specimens through a prospective interventional single-center trial The study will consist of two groups of patients one assigned to the standard fine needle biopsy FNB and the other to the mFNB The primary study outcomes will include sample quality core integrity and diagnostic accuracy
Detailed Description:
The development of Endoscopic ultrasound-guided tissue acquisition EUS-TA has been remarkable Initially focused on obtaining samples from the pancreas it has expanded significantly to include various organs adjacent to the gastrointestinal system ie liver lymph nodes adrenal glands
One of the key advancements in EUS-TA involves the shift from cytological analysis with fine-needle aspiration FNA to histological and even genetic evaluations with fine-needle biopsies FNB FNB addresses some limitations associated with FNA such as low tumor cellularity and the inability to retain cellular architecture
Recent improvements in puncture techniques and needles allow for the collection of high-quality specimens comparable to core needle biopsy to achieve standards for specimen adequacy ie intact liver cores of at least 15-20 mm with a complete portal triad count of 11 Some current available needle designs include the crown type flanged type 20 Gauge FNB needles with forward-faced core traps and the fork-tip needles demonstrating high diagnostic accuracy and a low rate of adverse events
The Precision-GI is a new motorized fine needle mFNB developed by LIMACA Medical in Israel for EUS-guided FNB It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition Moreover a sharp stylet facilitates crossing through the gastrointestinal wall allowing for the reach of target lesions The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage
In the present study the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens The study will consist of two groups of patients one assigned to the standard fine needle biopsy FNB and the other to the mFNB The primary study outcomes will include sample quality core integrity and diagnostic accuracy
One of the key advancements in EUS-TA involves the shift from cytological analysis with fine-needle aspiration FNA to histological and even genetic evaluations with fine-needle biopsies FNB FNB addresses some limitations associated with FNA such as low tumor cellularity and the inability to retain cellular architecture
Recent improvements in puncture techniques and needles allow for the collection of high-quality specimens comparable to core needle biopsy to achieve standards for specimen adequacy ie intact liver cores of at least 15-20 mm with a complete portal triad count of 11 Some current available needle designs include the crown type flanged type 20 Gauge FNB needles with forward-faced core traps and the fork-tip needles demonstrating high diagnostic accuracy and a low rate of adverse events
The Precision-GI is a new motorized fine needle mFNB developed by LIMACA Medical in Israel for EUS-guided FNB It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition Moreover a sharp stylet facilitates crossing through the gastrointestinal wall allowing for the reach of target lesions The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage
In the present study the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens The study will consist of two groups of patients one assigned to the standard fine needle biopsy FNB and the other to the mFNB The primary study outcomes will include sample quality core integrity and diagnostic accuracy
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?:
False
Is an FDA AA801 Violation?:
None