Actively Recruiting
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Led by Promedon · Updated on 2024-11-22
140
Participants Needed
7
Research Sites
393 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
CONDITIONS
Official Title
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-fertile women
- Primary symptomatic uterine descent with POP-Q stage 2 or higher
- Scheduled for apical pelvic organ prolapse repair using Splentis
- Willing and able to participate in study visits and provide informed consent
You will not qualify if you...
- Fertile women
- Recurrent apical prolapse
- Women with vaginal vault prolapse after hysterectomy
- Active or latent infection of the vagina, cervix, or uterus
- Previous or current vaginal, cervical, or uterine cancer
- Previous, current, or planned pelvic radiation therapy
- Known allergy to polypropylene
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
DRK Hospital Chemnitz-Rabenstein
Chemnitz, Germany
Actively Recruiting
2
Helios Hospital Erfurt, Department of gynaecology
Erfurt, Germany
Actively Recruiting
3
University Hospital Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
4
Clinic Kassel
Kassel, Germany
Actively Recruiting
5
St. Elisabeth Hospital
Leipzig, Germany
Actively Recruiting
6
University Hospital
Mannheim, Germany
Not Yet Recruiting
7
Hospital Tettnang
Tettnang, Germany
Actively Recruiting
Research Team
P
Philipp Schelhorn
CONTACT
L
Lorena López, Ph.D, Bioeng
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here