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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.
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.
Primary Outcome
Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.
Conditions Studied
Interventions
- DEVICE balloon implant
- PROCEDURE Balloon implantation
Study Locations (1)
Virginia
- Virginia Commonwealth University School of Medicine, Massey Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-05 |
| Phase | NA |
What the finished NCT00918229 record still lists
NCT00918229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00918229's enrollment target sits among peer trials
24 634th of 735 higher than 97 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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