Uterine Prolapse Without Vaginal Wall ProlapseNCT03436979
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
An observational study of Uterine Prolapse Without Vaginal Wall Prolapse, run by Pop Medical Solutions at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 84 years, women only
- Conditions the study is for
- Uterine Prolapse Without Vaginal Wall Prolapse
- What is being tested?
- NeuGuide™ System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 1 Jan 2018to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 84 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are undergoing surgical treatment for uterine prolapse.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States11 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Maimonides Medical Center
Brooklyn, New York, 11220
Mount Auburn Hospital
Cambridge, Massachusetts, 02138
Cleveland Clinic Cleveland
Cleveland, Ohio, 44195
Walnut Hill OB/GYN Associates
Dallas, Texas, 75231
INOVA Women's Hospital
Falls Church, Virginia, 22046
Holy Cross Hospital
Fort Lauderdale, Florida, 33364
Female Pelvic Health Center
Newtown, Pennsylvania, 18940
South Nassau Community Hospital Cancer Center
Valley Stream, New York, 11580
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Cleveland Clinic Florida
Weston, Florida, 33331
Germany3 sites
Krankenhaus Waldfriede
Berlin-Zehlendorf, 14163
Isar Kliniken GmbH
München
St. Joseph Krankenhaus
Tempelhof
About this study
Official title: The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
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.
- Being tested
- NeuGuide™ System
- Keywords
- prolapse, sacrospinous fixation, minimally invasive
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuGuide™ SystemDevice
Also called transvaginal sacrospinous ligament fixation
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System. Receives: Device: NeuGuide™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Primary composite performance outcome
Measured: 12 months
The number of device / procedure related Serious Adverse Events (SAE).
Primary safety of surgical implantation as reflected by adverse events
Measured: 30 days
The number of Serious Adverse Events and Adverse Events.
Primary safety of NeuGuide treatment as reflected by adverse events
Measured: 12 months
Secondary outcomes (13)
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Measured: one month
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Measured: 6 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical of the NeuGuide treatment
Measured: 12 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment outcome
Measured: 24 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Measured: 36 months
Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.
Secondary performance: durability of the NeuGuide treatment
Measured: 36 months
Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.
Secondary symptomatic performance of the NeuGuide treatment
Measured: 12 months
The time utilization of staff performing the NeuGuide procedure.
Secondary outcome: Cost performance of the procedure
Measured: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Measured: Baseline
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Measured: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Measured: 12 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Measured: 24 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Prolapse Without Vaginal Wall ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pop Medical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James C Leiter, M.D., Study director, Avania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436979
- Sponsor's protocol ID
- 06-CLP-0098
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2018
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data a available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
- ClinicalTrials.gov ID
- NCT03436979
- Acronym / sponsor ID
- 06-CLP-0098
- Keywords
- prolapse, sacrospinous fixation, minimally invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pop Medical SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Device: NeuGuide™ SystemSubjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System. |
Who may qualify
- Ages
- 36 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are undergoing surgical treatment for uterine prolapse.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuGuide™ SystemAlso: transvaginal sacrospinous ligament fixationThe NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. | Device | Subjects |
Primary outcome
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.
Time frame: 12 months
Primary composite performance outcome
The number of device / procedure related Serious Adverse Events (SAE).
Time frame: 30 days
Primary safety of surgical implantation as reflected by adverse events
The number of Serious Adverse Events and Adverse Events.
Time frame: 12 months
Primary safety of NeuGuide treatment as reflected by adverse events
13 secondary outcomes
Change in mean POP-Q C point score from baseline (cm).
Time frame: one month
Change in mean POP-Q C point score from baseline (cm).
Time frame: 6 months
Change in mean POP-Q C point score from baseline (cm).
Time frame: 12 months
Change in mean POP-Q C point score from baseline (cm).
Time frame: 24 months
Change in mean POP-Q C point score from baseline (cm).
Time frame: 36 months
Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.
Time frame: 36 months
Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.
Time frame: 12 months
The time utilization of staff performing the NeuGuide procedure.
Time frame: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Time frame: Baseline
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Time frame: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Time frame: 12 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Time frame: 24 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data a available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Leiter, M.D. study director
Avania
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Prolapse Without Vaginal Wall Prolapse, run by Pop Medical Solutions at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.