Trials / Completed
CompletedNCT03998566
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Early Feasibility Study For Evaluation Of The TraceIT® Tissue Spacer For Creating Space Between The Duodenum And Pancreas In Patients With Localized Pancreatic Cancer Undergoing Radiation Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TraceIT Tissue Spacer implantation | The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. |
Timeline
- Start date
- 2019-04-24
- Primary completion
- 2021-05-01
- Completion
- 2021-05-01
- First posted
- 2019-06-26
- Last updated
- 2023-02-27
- Results posted
- 2023-02-27
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03998566. Inclusion in this directory is not an endorsement.