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Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms

NCT03435770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-02-20

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency waves under ultrasound imaging. The subject who will be recruited into this study are patients who are deemed as non-surgical candidates.

Conditions

Interventions

DEVICE

EUSRA RFA needle

A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Yung Ka Chin, MBChB · Department of Gastroenterology & Herpetology, Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • Singapore

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 NCT03435770 on ClinicalTrials.gov