Trials / Completed
CompletedNCT03109041
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- CivaTech Oncology · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CivaSheet | The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures. |
Timeline
- Start date
- 2017-09-06
- Primary completion
- 2022-12-01
- Completion
- 2023-06-30
- First posted
- 2017-04-11
- Last updated
- 2023-09-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03109041. Inclusion in this directory is not an endorsement.