Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136819
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-11-09
Brief Title:
RT-310 Dose Escalation BPH Study
Sponsor:
Resurge Therapeutics Inc
Organization:
Resurge Therapeutics Inc
Study Overview
Official Title:
Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms LUTS Secondary to Benign Prostatic Hyperplasia BPH
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RT-310 a novel implant is intended to minimally invasive treat locally the prostate gland for the management of prostate disease while minimizing side-effects The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population
Detailed Description:
The RT-310 study is a first in human Phase 1 multi-center prospective non-randomized dose escalation study to evaluate the safety and feasibility of RT-310 for treatment of Benign Prostatic Hyperplasia BPH Study participants will have placement of RT-310 and be followed through 180 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None