Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDAMED No: CIV-24-09-049116 | Other Identifier | EU (European Commission) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
LatGYNious is a preformed mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh arms, which achieves a strong lateral fixation. The overlap area of the two mesh types is designed to combine the properties of both structures. In case of a uterus preserving approach, the posterior part of the mesh body is removed.
The aim of the present study is to generate clinical data to show the safety and performance of LatGYNious for the treatment of female pelvic organ prolapse.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic lateral suspension with surgical mesh (LatGYNious) | Device | Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective success | The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant. Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively. Objective cure is defined as:
| During follow-up until 6 and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | Quality of Life is determined by a validated questionnaire (P-QoL). The P-QoL Total score ranging from 0 points (complete continence) to 24 points (complete incontinence). An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up). | During follow-up until 6 and 12 months after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Blab | Contact | +43 5522 90505 4062 | florian.blab@ami.at |
| Name | Affiliation | Role |
|---|---|---|
| Tina Cadenbach-Blome, Dr. med. | Medizincampus Bodensee - Klinik Tettnang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BZK St. Johann in Tirol | Recruiting | Sankt Johann in Tirol | Tyrol | 6380 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Subjective success | Subjective rating of pelvic floor function is determined by a validated questionnaire (Deutscher Beckenboden-Fragebogen / German Pelvic Floor Questionnaire (GPFQ)). The GPFQ consist of 42 items, where each item has its scores. The scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21). The final score were calculated as follows: (achieved value of category/ max. value of category)*10 Therefore, the max. value is 10 for each category and the final score is maximum 40. An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up). | During follow-up until 6 and 12 months after surgery |
| Complications | All adverse events will be reported. Serious device- and procedure-related adverse events will be summarized separately. | From operation during follow-up until 6 and 12 months after surgery. |
| LKH Feldkirch, Gynäkologie und Geburtshilfe | Recruiting | Feldkirch | 6800 | Austria |
|
| Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe | Not yet recruiting | Brandenburg | 14770 | Germany |
|
| Krankenhaus St. Joseph-Stift Bremen | Not yet recruiting | Bremen | 28209 | Germany |
|
| Medizincampus Bodensee - Klinik Tettnang | Not yet recruiting | Tettnang | 88069 | Germany |
|
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013526 | Surgical Mesh |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided