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

Description

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

December 2018

Interventions

  • Device: NeuGuide™ System

Study ID

Pop Medical Solutions -- 06-CLP-0098

Status

Unknown

Trial ID

NCT03436979

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

60

Sponsor

Pop Medical Solutions

Inclusion Criteria

    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 over-reduction). 2. Patient planned for elective uterine prolapse surgical procedure. 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 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 anti-microbial treatment. 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 systems. 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 results. 19. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

Gender

Female

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
South Nassau Community Hospital Cancer Center - Valley Stream, New York 44.6 miles Evelyn Surillo 516-632-3312 Surillo@snch.org
The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown, Pennsylvania 124.2 miles Eileen Taff 610-730-2502 etaff@fpminstitute.com
MedStar Health Research Institute - Washington, District of Columbia 255.3 miles Patricia Tanjutco MD 202-877-5811 Patricia.Tanjuctco@medstar.net
INOVA Womens Hospital - Falls Church, Virginia 263.5 miles Rashmi Mishra MBBS 703-776-7140 Rashmi.Mishra@inova.org
Cleveland Clinic Florida - Weston, Florida 1,126.5 miles Calvin Killingbeck 954 659-6247 killinc@ccf.org

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