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ACTIVE NOT RECRUITING
NCT03821142
NA

Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

Sponsor: Promedon

View on ClinicalTrials.gov

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

Official title: Prospective, Multicenter, 60 Months, Single Arm Cohort Study to Evaluate the Efficacy and Safety of the Ultra-Light-Weight Mesh CAlistar S in Transvaginal Pelvic Organ Prolapse Repair

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2021-03-10

Completion Date

2029-10

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DEVICE

Transvaginal mesh for anterior pelvic organ prolapse repair

synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population

Locations (6)

Helios Hospital Erfurt, Department of gynaecology

Erfurt, Thuringia, Germany

St. Hedwig Hospital

Berlin, Germany

Evangelic Diakonie Hospital

Freiburg im Breisgau, Germany

St. Elisabeth-Hospital Leipzig

Leipzig, Germany

Hospital Tettnang

Tettnang, Germany

University Hospital Tübingen

Tübingen, Germany