Retrospective Data Analysis PelviGYNious/EndoGYNious

A.M.I. Agency for Medical Innovations

Status

Active, not recruiting

Conditions

Pelvic Organ Prolapse (POP)

Sacrocolpopexy

Prolapse

Treatments

Device: PelviGYNious

Device: EndoGYNious

Study type

Observational

Funder types

Industry

Identifiers

PMCF-4.2-004

Details and patient eligibility

About

The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.

Enrollment

80 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Exclusion criteria

Patients who rule out subsequent contact by the hospital will be excluded.

The use of the products is contraindicated in case of:

pregnancy and/or patients who consider future pregnancies
adolescent/ pubescent patients
existence of a known sensitivity/ allergy against plastic materials such as polypropylene, polyester, etc.
any pathology, including known or suspected uterine pathology, which would compromise placement of the implant/mesh (e.g. anatomical distortion or abnormalities)
known anticoagulation disorder
anticoagulant therapy
autoimmune connective tissue disease
renal insufficiency and upper urinary tract obstruction
cancer illnesses of the vagina / cervix / rectum
undergone radiation therapy on the vagina, cervix, rectum
planned or emergency opening of the gastro-intestinal tract, as this could cause a risk of product contamination that could lead to infection that would require removal of the implant/device
active or latent infection especially of the genital system and/or urinary tract