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Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

NCT03998566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-27

Study results available
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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

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2021-05-01
Completion
2021-05-01
FDA Device
Yes

Countries

  • United States

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 NCT03998566 on ClinicalTrials.gov