Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

NCT ID: NCT05354440

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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BioProtect

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Luke's Radiation Oncology

Dublin, , Ireland

Site Status

Assuta Ashdod medical center

Ashdod, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Maastricht radiation oncology

Maastricht, , Netherlands

Site Status

Institute of Maria Skłodowska - Curie

Warsaw, , Poland

Site Status

Cuf Porto institution

Porto, , Portugal

Site Status

Countries

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Ireland Israel Netherlands Poland Portugal

Other Identifiers

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CLP-10441

Identifier Type: -

Identifier Source: org_study_id

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