U.S., Feb. 4 -- ClinicalTrials.gov registry received information related to the study (NCT06805006) titled 'I-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)' on Jan. 28.
Brief Summary: The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
Study Start Date: Jan. 01
Study Type: OBSERVATIONAL
Condition:
Pelvic Organ Prolapse
Genital Prolapse
Intervention:
DEVICE: SSLF
Bilateral sacrospinous ligament fixation with i-Stitch device
Recruitment Status: ENROLLING_BY_INVITATION
Sponsor: A.M.I. Agency for Medical Innovations GmbH
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