Pelvic Organ Prolapse (POP)Genital ProlapseUterus ProlapseLaparoscopic Surgery
Investigational drug(s) / intervention(s)
Laparoscopic lateral suspension with surgical mesh (LatGYNious)
Laparoscopic lateral suspension with surgical mesh (LatGYNious): Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
Study summary
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
* Subject is candidate for a surgical treatment of pelvic organ prolapse
* Subject is willing and able to cooperate with follow-up examinations
* Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.
Exclusion Criteria:
* Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)
* Active immunotherapy which may negatively affect the treatment with a surgical mesh
* Active cancer of the vagina / cervix / rectum
* . known or suspected hypersensitivity to Polypropylene
* Pregnancy
* participation in another study at the same time
* Unable to understand study requirements or is unable to comply with follow-up schedule
* Contraindicated according to the instruction for use of the device
Primary outcome measure(s)
Objective success — During follow-up until 6 and 12 months after surgery The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant.
Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively.
Objective cure is defined as:
* POP-Q values Ba, C and Bp \< -1 (according to Barber et al.).
* Absence of pelvic floor prolapse/bulge symptoms based on questionnaire (P-QoL).
* No additional POP treatment necessary
Trial sites (5)
Facility
City
Region
Status
BZK St. Johann in Tirol
Sankt Johann in Tirol
Tyrol
Recruiting
Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe
Wiener Neustadt
Austria
Recruiting
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
Brandenburg
Germany
Not Yet Recruiting
Krankenhaus St. Joseph-Stift Bremen
Bremen
Germany
Not Yet Recruiting
Medizincampus Bodensee - Klinik Tettnang
Tettnang
Germany
Not Yet Recruiting
More A.M.I. Agency for Medical Innovations GmbH trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.