Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05354440

Acronym

CLP-10441

Enrollment

Registered

2022-04-29

Start date

2022-01-01

Completion date

2026-01-31

Last updated

2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

Detailed description

Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT following implantation of the BioProtect Balloon Implant System.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment. 2. Subject agrees to complete all required follow-up visits. 3. Subject provides written Informed Consent prior to any study related procedure

Exclusion criteria

1. Subject who completed 48 months of follow-up in the BP-007 study. 2. Subjects who are receiving at the time of the study, any other investigational agents/ devices. 3. Subjects unwilling and/or unable to comply with the provisions of the study protocol.

Design outcomes

Primary

Measure	Time frame	Description
Long Term Rectal And Urinary Toxicity and Quality of Life	48 months	Long-term safety as assessed by incidence of urinary and bowel toxicities.

Countries

Ireland, Israel, Netherlands, Poland, Portugal

Outcome results