The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse (NCT03436979) | Clinical Trial Compass
CompletedNot Applicable
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
United States, Germany, Israel60 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 NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
Who can participate
Age range
36 Years – 84 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 NeuGuide™ 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.