A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.
NCT03076216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2021-07-13
Summary
To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements.
The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.
Conditions
- Unresectable Locally Advanced Pancreatic Carcinoma
Interventions
- DEVICE
-
OncoSil™
The implantation of OncoSil™ under EUS
Sponsors & Collaborators
-
OncoSil Medical Limited
lead INDUSTRY
Principal Investigators
-
Joseph M Herman, M.D., M.Sc. · MD Anderson Cancer Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-01
- Primary Completion
- 2020-11-28
- Completion
- 2020-11-28
- FDA Device
- Yes
Countries
- United States
Study Locations
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