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Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

NCT00918229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-11-20

Study results available
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Summary

Primary Goal

The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.

Secondary Goal

The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Conditions

Interventions

DEVICE

balloon implant

Absorbable perirectal spacer implantation

PROCEDURE

Balloon implantation

Implantation of the balloon between the prostate and the anterior rectal wall

Sponsors & Collaborators

  • BioProtect

    lead INDUSTRY

Principal Investigators

  • Yossi Muncher, Dr. · BioProtect

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-05-31
Completion
2011-05-31
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 NCT00918229 on ClinicalTrials.gov