Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
80 participants
OBSERVATIONAL
2024-04-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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EndoGYNious
Patient received EndoGYNious mesh implant.
EndoGYNious
Patient received EndoGYNious implant.
PelviGYNious
Patient received PelviGYNious mesh implant.
PelviGYNious
Patient received PelviGYNious implant.
Interventions
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PelviGYNious
Patient received PelviGYNious implant.
EndoGYNious
Patient received EndoGYNious implant.
Eligibility Criteria
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Inclusion Criteria
* Implantation of either EndoGYNious or PelviGYNious
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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A.M.I. Agency for Medical Innovations GmbH
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Erlangen, Frauenklinik
Erlangen, , Germany
Countries
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Other Identifiers
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PMCF-4.2-004
Identifier Type: -
Identifier Source: org_study_id
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