Uterine Prolapse Without Vaginal Wall Prolapse Clinical Trial
Official title:
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
| Verified date | November 2023 |
| Source | Pop Medical Solutions |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | August 31, 2024 |
| Est. primary completion date | October 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 36 Years to 84 Years |
| Eligibility | Inclusion Criteria: 1. Patient with POP-Q C point greater than (-) 1 cm. 2. Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study. 3. Non-pregnant female (female of child bearing potential must have a negative pregnancy test). 4. Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments. 5. Patient is able to complete written questionnaires. 6. Patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone. Exclusion Criteria: 1. Known diagnosis of reproductive tract abnormalities. 2. Prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease. 3. Known history of severe Pelvic Inflammatory Disease (PID). 4. Prior total hysterectomy. 5. Prior pelvic prolapse surgery using synthetic mesh. 6. Pathological PAP in the past year. 7. Moderate or severe bacterial cervicitis. 8. Moderate or severe pelvic pain (> 3 on VAS). 9. Severe morbid obesity (BMI >45). 10. Temperature > 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment. 11. Significant cognitive impairment. 12. Active malignancy other than non-melanoma skin cancer. 13. Planned surgery (more than a minor one) in the next 30 days. 14. Patient has a known hypersensitivity to device materials (Nickel, suture material). 15. Moribund patient or patient with severe or deteriorating damage in critical body systems. 16. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results. 17. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | St. Joseph Krankenhaus | Berlin-Tempelhof | |
| Germany | Krankenhaus Waldfriede | Berlin-Zehlendorf | |
| Germany | Isar Kliniken GmbH | München | |
| Israel | Soroka Medical Center | Be'er Sheva | |
| United States | The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania |
| United States | Maimonides Medical Center | Brooklyn | New York |
| United States | Mount Auburn Hospital | Cambridge | Massachusetts |
| United States | Cleveland Clinic Cleveland | Cleveland | Ohio |
| United States | Walnut Hill OB/GYN Associates | Dallas | Texas |
| United States | INOVA Women's Hospital | Falls Church | Virginia |
| United States | Holy Cross Hospital | Fort Lauderdale | Florida |
| United States | Female Pelvic Health Center | Newtown | Pennsylvania |
| United States | South Nassau Community Hospital Cancer Center | Valley Stream | New York |
| United States | MedStar Health Research Institute | Washington | District of Columbia |
| United States | Cleveland Clinic Florida | Weston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pop Medical Solutions |
United States, Germany, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | A composite of the Pelvic Organ Prolapse Quantification (POP-Q) C point score, patient-rated symptom of vaginal bulging after vaginal colpopexy performed using the NeuGuide™ and the absence of further surgical therapy for uterine prolapse. | Primary composite performance outcome | 12 months | |
| Primary | The number of device / procedure related Serious Adverse Events (SAE). | Primary safety of surgical implantation as reflected by adverse events | 30 days | |
| Primary | The number of Serious Adverse Events and Adverse Events. | Primary safety of NeuGuide treatment as reflected by adverse events | 12 months | |
| Secondary | Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment | one month | |
| Secondary | Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment | 6 months | |
| Secondary | Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical of the NeuGuide treatment | 12 months | |
| Secondary | Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment outcome | 24 months | |
| Secondary | Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment | 36 months | |
| Secondary | Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence. | Secondary performance: durability of the NeuGuide treatment | 36 months | |
| Secondary | Number of subjects in whom the primary symptomatic reason for repair of prolapse persists. | Secondary symptomatic performance of the NeuGuide treatment | 12 months | |
| Secondary | The time utilization of staff performing the NeuGuide procedure. | Secondary outcome: Cost performance of the procedure | one month | |
| Secondary | The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen | Secondary outcome: POP-Q Stage Score. | Baseline | |
| Secondary | The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen | Secondary outcome: POP-Q Stage Score. | one month | |
| Secondary | The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen | Secondary outcome: POP-Q Stage Score. | 12 months | |
| Secondary | The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen | Secondary outcome: POP-Q Stage Score. | 24 months | |
| Secondary | The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen | Secondary outcome: POP-Q Stage Score. | 36 months |