CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Absorbable perirectal spacerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00462124
NCT00462124N/ACompleted
CompareCT.gov

One-arm, Multi-center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

BioProtect·interventional·Posted Apr 18, 2007·Updated Aug 8, 2019

In Brief

A clinical study evaluating Absorbable perirectal spacer for Prostate Cancer. Completed, enrolled 7 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2007
Enrollment StartJun 1, 2007
Primary CompletionMar 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.2 years ago

Interventions

Absorbable perirectal spacerdevice

biodegradable balloon implant to increase the distance between prostate and anterior rectal wall