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NCT00918229 · ClinicalTrials.gov registry record · NA

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

A NA study of Prostate Cancer, sponsored by BioProtect.

Completed
Registry status
NA
Development phase
24
Enrollment target
1
Study location

NCT00918229: Completed NA study of Prostate Cancer, sponsored by BioProtect.

NCT00918229 is a NA study of Prostate Cancer that has completed, run by BioProtect. The registered enrollment target is 24 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00918229, a NA study of Prostate Cancer, has completed, sponsored by BioProtect.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target
1
Study location

Study 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 Studied

Prostate Cancer

Interventions

  • DEVICE balloon implant
  • PROCEDURE Balloon implantation

Study Locations (1)

Virginia

  • Virginia Commonwealth University School of Medicine, Massey Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-06
Est. Completion 2011-05
Phase NA

Sponsor

BioProtect

4 total trials

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What the Registry Record Tells You About NCT00918229

The ClinicalTrials.gov registry entry for NCT00918229 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The listed sponsor is BioProtect, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which balloon implant is the first listed.

NCT00918229 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT00918229 about?

NCT00918229 is a clinical study titled "Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects". 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. ...

What is the current status of trial NCT00918229?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2009-06. Estimated completion is 2011-05.

What conditions does trial NCT00918229 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT00918229?

The interventions under investigation include: balloon implant (DEVICE), Balloon implantation (PROCEDURE).

Who is sponsoring clinical trial NCT00918229?

This trial is sponsored by BioProtect, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00918229 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.