NCT07012694Not yet recruiting
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
A Prospective, Multicenter, Blinded, Randomized Controlled Trial Assessing the Diagnostic Yield and Tissue Adequacy of 22G Adapt Versus 22G Franseen Fine-Needle Biopsy for Solid Lesions Under Endoscopic Ultrasound Guidance
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 576 (estimated)
- First submitted
- 25 May 2025
- Start date
- Jul 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Huazhong University of Science and Technology
- Diseases
- Pancreatic cancer
- NCT number
- NCT07012694
What you commit to
- Study type: Interventional
- Planned participants: 576
- From Jul 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- inability to safely perform Endoscopic Ultrasound-Guided Tissue Acquisition (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
Lab values
- Hemoglobin ≤8.0 g/dL;
- Coagulation disorders(Platelet \<50,000/mm3, International Normalized Ratio \> 1.5);
Other
- Pregnant women;
- Took anticoagulants such as aspirin, warfarin in the latest week;
- Acute pancreatitis in the past two weeks;
Who the study is looking for
- Over 18 years old and under 85 years old;
- Presence of a solid lesion greater than 1 cm in diameter, as identified by cross-sectional imaging (Magnetic Resonance Imaging, Computed Tomography or abdominal ultrasound), located in anatomical regions accessible via endoscopic ultrasound (EUS)-including but not limited to the pancreas, retroperitoneum, liver, mediastinum, or subepithelial layers of the gastrointestinal tract-where tissue acquisition is clinically indicated to establish a definitive histopathological diagnosis.;
- Must be able to receive examinations in the research center;
- Must be able to sign the informed consent.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.