The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse

Pop Medical Solutions60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Uterine Prolapse Without Vaginal Wall Prolapse

Interventions

NeuGuide™ SystemDEVICE

The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.

Eligibility

Sex: FEMALEMin age: 36 YearsMax age: 84 Years

Medical Language ↔ Plain English

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.

Locations (15)

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

The number of device / procedure related Serious Adverse Events (SAE).

Primary safety of surgical implantation as reflected by adverse events

Time frame: 30 days

The number of Serious Adverse Events and Adverse Events.

Primary safety of NeuGuide treatment as reflected by adverse events

Time frame: 12 months