NCT05354440

Brief Summary

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

Trial Health

62
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
5 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

April 26, 2022

Last Update Submit

September 15, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Long Term Rectal And Urinary Toxicity and Quality of Life

    Long-term safety as assessed by incidence of urinary and bowel toxicities.

    48 months

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who previously participated in the BP-007 clinical study

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St Luke's Radiation Oncology

Dublin, Ireland

Location

Assuta Ashdod medical center

Ashdod, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Maastricht radiation oncology

Maastricht, Netherlands

Location

Institute of Maria Skłodowska - Curie

Warsaw, Poland

Location

Cuf Porto institution

Porto, Portugal

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 29, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)IL(2)PL(1)PT(1)NL(1)