MedTrace Logo

Motorized Fine Needle Biopsy vs Standard Needles

NCT06298604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

EUS-guided standard fine needle biopsy

Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 19-gauge standard fine needle biopsy device (Boston Scientific, USA) is inserted on it to obtain the sample or specimen.

DEVICE

EUS-guided motorized fine needle biopsy

Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 20-gauge motorized fine needle biopsy device (Limaca, Israel) is inserted on it to obtain the sample or specimen.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-09
Primary Completion
2024-10-09
Completion
2024-12-09

Countries

  • Ecuador

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298604 on ClinicalTrials.gov