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Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System (CLP-10441)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05354440
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
BioProtect

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

Condition or disease
Prostate Cancer

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Long Term Rectal And Urinary Toxicity and Quality of Life [ Time Frame: 48 months ]
    Long-term safety as assessed by incidence of urinary and bowel toxicities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who previously participated in the BP-007 clinical study
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05354440


Contacts
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Contact: Dafna Carmi-Yinon 972.54.4539515 dafna@bioprotect.com

Locations
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Israel
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Yarra Barr       yaaraba1@clalit.org.il   
Poland
Institute of Maria Skłodowska - Curie Recruiting
Warsaw, Poland
Contact: Mateusz Dabkowski, Dr.       mdabkowski@yahoo.com   
Sponsors and Collaborators
BioProtect
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Responsible Party: BioProtect
ClinicalTrials.gov Identifier: NCT05354440    
Other Study ID Numbers: CLP-10441
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases