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NCT06298604
Motorized Fine Needle Biopsy vs Standard Needles
NA trial testing EUS-guided standard fine needle biopsy in Pancreas Disease in 60 participants. Status unknown.
9 October 2024
Quick facts
| Lead sponsor | Instituto Ecuatoriano de Enfermedades Digestivas |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 9 December 2023 |
| Primary completion | 9 October 2024 |
| Estimated completion | 9 December 2024 |
| Sites | 1 location across Ecuador |
Drugs / interventions tested
- EUS-guided standard fine needle biopsy
- EUS-guided motorized fine needle biopsy
Conditions studied
- Pancreas Disease — all drugs for Pancreas Disease →
- Liver Diseases — all drugs for Liver Diseases →
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas — full company profile →
Who can join
Adults 18 to 99, any sex, with Pancreas Disease or Liver Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06298604
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Related trials
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Currently open trials in the same condition.
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- NCT05155878 — Prognostic Factors in Periampullary Tumors and Cysts · recruiting
- NCT03260842 — Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer · recruiting
Other Instituto Ecuatoriano de Enfermedades Digestivas trials
Trials by the same sponsor.
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- NCT06038201 — Cholecystectomy vs EUS-guided GBD With Stone Removal · NA · unknown
- NCT06279546 — Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06298604 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Ecuatoriano de Enfermedades Digestivas
- Last refreshed: 22 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06298604.
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