Retrospective Data Analysis PelviGYNious/EndoGYNious (NCT06927752) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Retrospective Data Analysis PelviGYNious/EndoGYNious
Germany80 participantsStarted 2024-04-01
Plain-language summary
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Surgery for POP
* Implantation of either EndoGYNious or PelviGYNious
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery
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
What they're measuring
1
Patient subjective outcome
Timeframe: From baseline to the end of last follow-up [3 months, 12 months]