22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions

NCT07012694 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2025-07-01

No results posted yet for this study

Summary

The investigators conduct a prospective, multicenter, blinded, randomized controlled trial to compare the diagnostic value and safety of the 22G Adapt needle versus the 22G Franseen needle for histopathological evaluation of solid lesions.

Conditions

  • Pancreatic Neoplasms
  • Mediastinal Neoplasms
  • Abdominal Neoplasm, Excluding Pancreas Neoplasm

Interventions

DEVICE

22G Franseen Needle Group

Fine-needle-biopsy (22G Franseen, Boston Scientific, Winston-Salem, USA)

DEVICE

22G Adapt Needle Group

Fine-needle-biopsy (22G Adapt, Micro.Tech Endoscopy, Nanjing, China)

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER
  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER
  • The First People's Hospital of Yunnan

    collaborator OTHER
  • The First Affiliated Hospital of University of Science and Technology of China

    collaborator OTHER
  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Bin Cheng · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-09-30
Completion
2026-12-10

Countries

  • China

Study Locations

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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 NCT07012694 on ClinicalTrials.gov