The NeuGuideâ„¢ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse (NCT03436979) | Clinical Trial Compass
CompletedNot Applicable
The NeuGuideâ„¢ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
United States60 participantsStarted 2018-01-01
Plain-language summary
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuideâ„¢ system when used for vaginal colpopexy in the treatment of uterine prolapse.
Who can participate
Age range36 Years – 84 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
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 NeuGuideâ„¢ and the absence of further surgical therapy for uterine prolapse.
Timeframe: 12 months
2
The number of device / procedure related Serious Adverse Events (SAE).
Timeframe: 30 days
3
The number of Serious Adverse Events and Adverse Events.