The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
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 Start Date
January, 01 2018
Estimated Completion Date
- Device: NeuGuide™ System
Pop Medical Solutions -- 06-CLP-0098
Pop Medical Solutions
1. Patient with POP-Q C point ? 0 cm (stage II or greater) and anterior and posterior
compartment prolapse with POP-Q Ba and Bp points < (-)1 cm (stage I prolapse, measured
after manual reduction of the cervix to the level of the ischial spines to avoid
2. Patient planned for elective uterine prolapse surgical procedure.
3. Non-pregnant female (female of child bearing potential must have a negative pregnancy
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.
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 hysterectomy or non-hysteroscopic myomectomy.
5. Prior pelvic prolapse surgery using synthetic mesh.
6. Cervical hypertrophy where D-C > 4 cm (i.e., cervix longer than 4 cm)
7. Pathological PAP in the past year.
8. Moderate or severe bacterial cervicitis.
9. Known overt or occult stress incontinence.
10. Moderate or severe pelvic pain (> 3 on VAS).
11. Severe morbid obesity (BMI >40).
12. Temperature > 38°C (oral or equivalent), sepsis, or active infection requiring IV
13. Significant cognitive impairment.
14. Active malignancy other than non-melanoma skin cancer.
15. Planned surgery (more than a minor one) in the next 30 days.
16. Patient has a known hypersensitivity to device materials (Nickel, suture material).
17. Moribund patient or patient with severe or deteriorating damage in critical body
18. 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
19. Concurrent enrollment in another device or drug trial that has not completed the
primary endpoint or clinically interferes with the current study endpoints.
40 Years to 85 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (5)
|South Nassau Community Hospital Cancer Center - Valley Stream, New York||178.7 miles||Evelyn Surillo||516-632-3312||Surillo@snch.org|
|The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown, Pennsylvania||257.9 miles||Eileen Tafffirstname.lastname@example.org|
|MedStar Health Research Institute - Washington, District of Columbia||391.7 miles||Patricia Tanjutco MD||202-877-5811||Patricia.Tanjuctco@medstar.net|
|INOVA Womens Hospital - Falls Church, Virginia||400.0 miles||Rashmi Mishra MBBS||703-776-7140||Rashmi.Mishra@inova.org|
|Cleveland Clinic Florida - Weston, Florida||1,246.2 miles||Calvin Killingbeck||954 email@example.com|