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Balloon implant for prostate cancer passes Long-Term safety check

NCT ID NCT05354440

Disease control Sponsor: BioProtect Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 80 prostate cancer patients who previously received a BioProtect balloon implant during radiation therapy. Researchers are checking for long-term side effects in the bladder and bowel, and how patients' quality of life holds up over time. The goal is to make sure the implant remains safe years after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioProtect balloon implant system
What this could lead to
If successful, this study could confirm that the BioProtect balloon implant is a safe long-term option to reduce side effects during prostate cancer radiation therapy.
What could go wrong
This is a small, observational follow-up study with only 80 participants, so results may not apply to all patients. It does not test a new treatment, only monitors past outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects who previously participated in the BP-007 clinical study

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Assuta Ashdod medical center

    Ashdod, Israel

  • Cuf Porto institution

    Porto, Portugal

  • Institute of Maria Skłodowska - Curie

    Warsaw, Poland

  • Maastricht radiation oncology

    Maastricht, Netherlands

  • Rabin Medical Center

    Petah Tikva, Israel

  • St Luke's Radiation Oncology

    Dublin, Ireland

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