I-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF) (i-StitchSSLF)

A.M.I. Agency for Medical Innovations

Status: Invitation-only

Conditions: Genital Prolapse; Pelvic Organ Prolapse

Treatments: Device: SSLF

Study type: Observational

Funder types: Industry

Identifiers

NCT06805006

PMCF-03-011

Details and patient eligibility

About

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.

Full description

The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.

The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgery for POP
• SSLF with usage of i-Stitch device (& i-Stitch Loading Units)
• Concomitant procedures are allowed
• Women minimum 18 years old
• Written informed consent for surgery

Exclusion criteria

• infection (active or latent)
• allergies to the materials used
• benign or malignant changes
• anticoagulation disorders
• autoimmune connective tissue disorders
• any uterus pathologies