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 range
18 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient subjective outcome
Timeframe: From baseline to the end of last follow-up [3 months, 12 months]