Status:
ACTIVE_NOT_RECRUITING
Retrospective Data Analysis PelviGYNious/EndoGYNious
Lead Sponsor:
A.M.I. Agency for Medical Innovations GmbH
Conditions:
Prolapse
Sacrocolpopexy
Eligibility:
FEMALE
18+ years
Brief Summary
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
Eligibility Criteria
Inclusion
- Surgery for POP
- Implantation of either EndoGYNious or PelviGYNious
- Concomitant procedures are allowed
- Women minimum 18 years old
- Written informed consent for surgery
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06927752
Start Date
April 1 2024
End Date
August 1 2025
Last Update
April 15 2025
Active Locations (1)
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1
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, Germany