Clinical trial · Interventional
BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| balloon | Device | — | UNRESOLVED |
| Control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- balloon group
- description
- Marking + balloon implantation + IMRT
- interventionNames
- Device: balloon
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- Marking + IMRT
- interventionNames
- Other: Control
Primary outcomes (2)
- measure
- Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure
- timeFrame
- Within 6 months from balloon implantation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available