Status:
ACTIVE_NOT_RECRUITING
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Lead Sponsor:
Promedon
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
Detailed Description
Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile...
Eligibility Criteria
Inclusion
- Inclusion criteria Non-fertile women \> 18 years1 2. Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba ≥ -1 and where applicable C ≥ -1/2 TVL ).
- 3\. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.
- 4\. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent
- Exclusion criteria
- Fertile women
- Patients with active or latent infection of the vagina, cervix or uterus
- Patients with previous or current vaginal, cervical or uterine cancer
- Previous, current or planned pelvic radiation therapy
- Known allergy to polypropylene
- 7\. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03821142
Start Date
March 10 2021
End Date
October 1 2029
Last Update
November 22 2024
Active Locations (6)
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1
Helios Hospital Erfurt, Department of gynaecology
Erfurt, Thuringia, Germany
2
St. Hedwig Hospital
Berlin, Germany
3
Evangelic Diakonie Hospital
Freiburg im Breisgau, Germany
4
St. Elisabeth-Hospital Leipzig
Leipzig, Germany