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

Completed

Conditions studied: Uterine Prolapse Without Vaginal Wall Prolapse

In brief

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.

Key facts

Study ID

NCT03436979

Run by

Pop Medical Solutions

People needed

60

Starts

2018-01-01

Expected to finish

2023-10-31

Last updated by the study team

2025-08-07

Who can join

Age: 36 and older, up to 84. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient with POP-Q C point greater than (-) 1 cm.
• Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study.
• Non-pregnant female (female of child bearing potential must have a negative pregnancy test).
• Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments.
• Patient is able to complete written questionnaires.
• Patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.

You may not qualify if…

• Known diagnosis of reproductive tract abnormalities.
• Prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease.
• Known history of severe Pelvic Inflammatory Disease (PID).
• Prior total hysterectomy.
• Prior pelvic prolapse surgery using synthetic mesh.
• Pathological PAP in the past year.
• Moderate or severe bacterial cervicitis.
• Moderate or severe pelvic pain (> 3 on VAS).
• Severe morbid obesity (BMI >45).
• Temperature > 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment.
• Significant cognitive impairment.
• Active malignancy other than non-melanoma skin cancer.
• Planned surgery (more than a minor one) in the next 30 days.
• Patient has a known hypersensitivity to device materials (Nickel, suture material).
• Moribund patient or patient with severe or deteriorating damage in critical body systems.
• 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.
• Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

Where it is running

• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• South Nassau Community Hospital Cancer Center — Valley Stream, New York, United States
• Cleveland Clinic Cleveland — Cleveland, Ohio, United States
• The Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Female Pelvic Health Center — Newtown, Pennsylvania, United States
• Walnut Hill OB/GYN Associates — Dallas, Texas, United States
• INOVA Women's Hospital — Falls Church, Virginia, United States
• Krankenhaus Waldfriede — Berlin-Zehlendorf, Germany
• Isar Kliniken GmbH — München, Germany
• St. Joseph Krankenhaus — Tempelhof, Germany
• Soroka Medical Center — Beersheba, Israel

Full record on ClinicalTrials.gov

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