BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the balloon to reduce the radiation dose delivered to the anterior rectum. The balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Key facts
- Study ID
- NCT03400150
- Run by
- BioProtect
- People needed
- 222
- Starts
- 2018-01-03
- Expected to finish
- 2021-12-10
- Last updated by the study team
- 2025-02-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Be at least 18 years of age
- Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit)
- Be scheduled for radiation therapy (XRT) by means of IMRT
You may not qualify if…
- Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years
- Prior radical prostatectomy
- Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
- Prior radiotherapy to the pelvis, including brachytherapy
- History of prior surgery involving the rectum or anus
- Prior surgical procedure involving the peri-rectal and/or peri-prostatic area
Where it is running
- Western Radiation Oncology — Apple Valley, California, United States
- KSK Medical Center — Irvine, California, United States
- Advanced Urology Institute — Daytona Beach, Florida, United States
- Rush University Cancer Center — Chicago, Illinois, United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
- Chesapeake Urology Research Associates — Owings Mills, Maryland, United States
- Urology Nevada — Reno, Nevada, United States
- Advanced Radiation Center of New York — Lake Success, New York, United States
- New York University Langone Health — New York, New York, United States
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
- Assuta Ashdod — Ashdod, Israel
- Rabin Medical Center — Petah Tikva, Israel
- Maastro — Maastricht, Netherlands
- Institute of Maria Skłodowska-Oncology Centre — Warsaw, Poland
- CUF Porto Instituto — Porto, Portugal
- Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom
Full record on ClinicalTrials.gov
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