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This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.
Study visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioProtect Balloon Implant System | Experimental | The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioProtect Balloon Implantâ„¢ System | Device | The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry | Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy | 6 months |
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Inclusion Criteria:
Patients with prostate cancer ≥ 18 years of age.
Patients are in one of the following risk groups:
Planned for radiation treatment with rectal spacer.
Ability to understand and the willingness to sign a written informed consent form.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Radiation Centers of New York | New Hyde Park | New York | 11042 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |