Clinical trial • Phase I • Other

Clinical trial in Urinary incontinence

Phase I trial for Urinary incontinence. open-label. 15 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Urinary incontinence
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
25-07-2024
First CTIS Authorization Date
31-10-2024

Trial design

open-label Phase I trial across 2 sites in Poland.

Open Label
Yes
Target Sample Size
15

Eligibility

Recruits 15 No vulnerable populations selected; no specific consent or assent handling described..

Vulnerable Population
No vulnerable populations selected; no specific consent or assent handling described.

Recruitment

Planned Sample Size
15
Recruitment Window Months
17

Geography

Total Number Of Sites
2
Total Number Of Participants
15

Poland

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
562
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Nicolaus Copernicus Hospital
Department Name
Oddział urologii ogólnej i onkologicznej
Principal Investigator Name
Przemysław Adamczyk
Principal Investigator Email
urologia@med.torun.pl
Contact Person Name
Przemysław Adamczyk
Contact Person Email
urologia@med.torun.pl
Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
Klinika Urologii Ogólnej i Onkologicznej
Principal Investigator Name
Tomasz Drewa
Principal Investigator Email
t.drewa@wp.pl
Contact Person Name
Tomasz Drewa
Contact Person Email
t.drewa@wp.pl

Sponsor

Primary sponsor

Full Name
Nicolaus Copernicus University
Organisation Type
Educational Institution
Country Of Registered Address
Poland

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