i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Launched by A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH · Jan 28, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
FEMALE
Eligibility criteria
- 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
About A.M.I. Agency For Medical Innovations Gmbh
a.m.i. agency for medical innovations gmbh is a dedicated clinical trial sponsor focused on advancing healthcare through the development and management of innovative medical technologies and therapies. Committed to enhancing patient outcomes, the agency collaborates with pharmaceutical and biotechnology companies to design and conduct rigorous clinical trials that adhere to the highest regulatory standards. With a team of experienced professionals, a.m.i. leverages its expertise to streamline the clinical research process, ensuring efficient study execution and robust data collection. By fostering partnerships and promoting innovation, a.m.i. aims to contribute significantly to the evolution of modern medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Munich, Bavaria, Germany
Patients applied
Trial Officials
Ursula Peschers, Prof. Dr.
Principal Investigator
ISAR Klinikum Munich
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported