Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• non-fertile women
• primary symptomatic uterine descent POP-Q≥2
• Scheduled apical POP repair with Splentis
• Willing and able to participate at study visits and to sign informed consent
Locations
Other Locations
Germany
DRK Hospital Chemnitz-Rabenstein
RECRUITING
Chemnitz
Helios Hospital Erfurt, Department of gynaecology
RECRUITING
Erfurt
University Hospital Freiburg
RECRUITING
Freiburg Im Breisgau
Clinic Kassel
RECRUITING
Kassel
St. Elisabeth Hospital
RECRUITING
Leipzig
University Hospital
NOT_YET_RECRUITING
Mannheim
Hospital Tettnang
RECRUITING
Tettnang
Contact Information
Primary
Philipp Schelhorn
trials.de@promedon.com
00498031900400
Backup
Lorena López, Ph.D, Bioeng
lorena.lopez@promedon.com
005493514596072
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2030-07
Participants
Target number of participants: 140
Treatments
Hysteropexy using Splentis via vaginal route
Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis
Related Therapeutic Areas
Sponsors
Leads: Promedon