ProlapseNCT06927752
Retrospective Data Analysis PelviGYNious/EndoGYNious
An observational study of Prolapse and Sacrocolpopexy, run by A.M.I. Agency for Medical Innovations GmbH at 1 site in Germany.
Trial summary
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- What is being tested?
- PelviGYNious and EndoGYNious
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The planned clinical investigation is a retrospective chart review of clinical data. All patients who underwent surgery between January 2016 and December 2023 and met the inclusion criteria and no exclusion criteria were analyzed.
Who may be able to join
- Surgery for POP
- Implantation of either EndoGYNious or PelviGYNious
- Concomitant procedures are allowed
- Women minimum 18 years old
- Written informed consent for surgery
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Analysis PelviGYNious/EndoGYNious (PMCF-4.2-004)
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
- Conditions
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- Being tested
- PelviGYNious, EndoGYNious
- Keywords
- Sacrocolpopexy, Sacrocervicopexy, surgical mesh, laparoscopic mesh
- Medical subject headings
- Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelviGYNiousDevice
Patient received PelviGYNious implant.
EndoGYNiousDevice
Patient received EndoGYNious implant.
| Study group | Role | What they receive |
|---|---|---|
| EndoGYNious | Patient received EndoGYNious mesh implant. Receives: Device: EndoGYNious | |
| PelviGYNious | Patient received PelviGYNious mesh implant. Receives: Device: PelviGYNious |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient subjective outcome
Patient subjective outcome after POP treatment with EndoGYNious or PelviGYNious will be measured with a validated questionnaire (German Pelvic Floor Questionnaire "Deutscher Beckenboden-Fragebogen") . This questionnaire focus on 4 items (bladder, bowel, prolapse, sexuality).
Each item has its scores, scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21), Calculation: (achieved value of category/ max. value of category)*10; max. value 10 for each category, max. final score 40 The postoperative scores will be compared with the preoperative scores.
Measured: From baseline to the end of last follow-up [3 months, 12 months]
Secondary outcomes (2)
Postoperative complications
To analyze postoperative complications in women undergoing POP treatment with EndoGYNious or PelviGYNious during the follow up period. The occurrence of each complicaiton/adverse event will be compared to the occurrence of the same complication by similar products or other state of the art treatments
Measured: From baseline to the end of last follow-up [average of minimum 3 months]
Anatomical success (POP-Q)
POP-Q system according to ICS with POP-Q stages 0, I, II, III, IV The postoperative POP-Q stages (overall, apical compartment, anterior compartment, posterior compartment) will be compared to the preoperative POP-Q stages.
Measured: From baseline to the end of last follow-up [average of minimum 3 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Apr 2024
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927752
- Sponsor's protocol ID
- PMCF-4.2-004
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis PelviGYNious/EndoGYNious (PMCF-4.2-004)
- ClinicalTrials.gov ID
- NCT06927752
- Acronym / sponsor ID
- PMCF-4.2-004
- Conditions
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- Keywords
- Sacrocolpopexy, Sacrocervicopexy, surgical mesh, laparoscopic mesh
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoGYNious | – | Device: EndoGYNiousPatient received EndoGYNious mesh implant. |
| PelviGYNious | – | Device: PelviGYNiousPatient received PelviGYNious mesh implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The planned clinical investigation is a retrospective chart review of clinical data. All patients who underwent surgery between January 2016 and December 2023 and met the inclusion criteria and no exclusion criteria were analyzed.
Key inclusion criteria (5 listed)
- Surgery for POP
- Implantation of either EndoGYNious or PelviGYNious
- Concomitant procedures are allowed
- Women minimum 18 years old
- Written informed consent for surgery
Key exclusion criteria (14 listed)
- Patients who rule out subsequent contact by the hospital will be excluded.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelviGYNiousPatient received PelviGYNious implant. | Device | PelviGYNious |
| EndoGYNiousPatient received EndoGYNious implant. | Device | EndoGYNious |
Primary outcome
Patient subjective outcome
Time frame: From baseline to the end of last follow-up [3 months, 12 months]
Patient subjective outcome after POP treatment with EndoGYNious or PelviGYNious will be measured with a validated questionnaire (German Pelvic Floor Questionnaire "Deutscher Beckenboden-Fragebogen") . This questionnaire focus on 4 items (bladder, bowel, prolapse, sexuality). Each item has its scores, scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21), Calculation: (achieved value of category/ max. value of category)*10; max. value 10 for each category, max. final score 40 The postoperative scores will be compared with the preoperative scores.
2 secondary outcomes
Postoperative complications
Time frame: From baseline to the end of last follow-up [average of minimum 3 months]
Anatomical success (POP-Q)
Time frame: From baseline to the end of last follow-up [average of minimum 3 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse and Sacrocolpopexy, run by A.M.I. Agency for Medical Innovations GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient subjective outcome (time frame: From baseline to the end of last follow-up [3 months, 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.