Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433596
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-23
Brief Title:
Autologous PRP and Focal Shock Waves for Erectile Dysfunction
Sponsor:
Elexial Research Limited
Organization:
Elexial Research Limited
Study Overview
Official Title:
Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to learn if Platelet-rich plasma PRP combined with Shock-wave therapy SWT works to treat moderate or mild to moderate erectile dysfunction It will also learn about the safety of this combined therapy
The main questions it aims to answer are
Does Combined therapy PRP SWT improve erection in men with moderate or mild to moderate erectile dysfunction
What medical problems do participants have when receiving Combined therapy PRP SWT
Researchers will compare Combined therapy PRP SWT to placebo therapy a look-alike substance that contains no PRP to see if Combined therapy PRP SWT works to treat moderate or mild to moderate erectile dysfunction
Participants will
Take a lab test to evaluate their platelets
Answer some questionnaires to assess your erectile function
Receive Combined therapy PRP SWT 3 sessions PRP 6 sessions SWT or placebo therapy for 9 weeks
Visit the clinic one month 3 months and 6 months after finishing the treatment for checkups and tests
The main questions it aims to answer are
Does Combined therapy PRP SWT improve erection in men with moderate or mild to moderate erectile dysfunction
What medical problems do participants have when receiving Combined therapy PRP SWT
Researchers will compare Combined therapy PRP SWT to placebo therapy a look-alike substance that contains no PRP to see if Combined therapy PRP SWT works to treat moderate or mild to moderate erectile dysfunction
Participants will
Take a lab test to evaluate their platelets
Answer some questionnaires to assess your erectile function
Receive Combined therapy PRP SWT 3 sessions PRP 6 sessions SWT or placebo therapy for 9 weeks
Visit the clinic one month 3 months and 6 months after finishing the treatment for checkups and tests
Detailed Description:
The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy compared with placebo for the treatment of moderate or mild to moderate erectile dysfunction measured as improvement in the IIEF-EF questionnaire score
Study design Randomized double-blind placebo-controlled clinical trial phase III The study will include four groups
G1 - Autologous PRP Autologous Platelet Rich Plasma PRP placebo shock waves
G2 - combined therapy Autologous PRP focal shock waves
G3 - placebo control Placebo PRP placebo shock waves
G4 - shock waves PRP placebo shock waves
116 subjects will be included who will be randomized in a 1111 ratio in the four groups described above
The change in the International Index of Erectile Function - Erectile Function domain IIEF-EF score the change in the Erection Hardness Score EHS and the adverse events will be evaluated at the end of treatment and 1 3 and 6 months of follow-up
Study design Randomized double-blind placebo-controlled clinical trial phase III The study will include four groups
G1 - Autologous PRP Autologous Platelet Rich Plasma PRP placebo shock waves
G2 - combined therapy Autologous PRP focal shock waves
G3 - placebo control Placebo PRP placebo shock waves
G4 - shock waves PRP placebo shock waves
116 subjects will be included who will be randomized in a 1111 ratio in the four groups described above
The change in the International Index of Erectile Function - Erectile Function domain IIEF-EF score the change in the Erection Hardness Score EHS and the adverse events will be evaluated at the end of treatment and 1 3 and 6 months of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002985-34 | EUDRACT_NUMBER | None | None |