MedTrace Logo

SpaceOAR System Pivotal Study

NCT01538628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2021-03-19

Study results available
· View outcomes & findings →

Summary

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

Conditions

Interventions

DEVICE

SpaceOAR System

Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

Sponsors & Collaborators

  • Augmenix, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-07-31
Completion
2014-07-31

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 NCT01538628 on ClinicalTrials.gov