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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 36 Years and 84 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Subjects Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.
  • Device: NeuGuide™ System
    The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
    Other names:
    • transvaginal sacrospinous ligament fixation

More Details

Status
Active, not recruiting
Sponsor
Pop Medical Solutions

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.