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

August 3, 2025 updated by: Pop Medical Solutions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin-Tempelhof, Germany
        • St. Joseph Krankenhaus
      • Berlin-Zehlendorf, Germany, 14163
        • Krankenhaus Waldfriede
      • München, Germany
        • Isar Kliniken GmbH
  • Israel
      • Be'er Sheva, Israel
        • Soroka Medical Center
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Florida
      • Fort Lauderdale, Florida, United States, 33364
        • Holy Cross Hospital
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Mount Auburn Hospital
    • New York
      • Brooklyn, New York, United States, 11220
        • Maimonides Medical Center
      • Valley Stream, New York, United States, 11580
        • South Nassau Community Hospital Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cleveland
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • The Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Newtown, Pennsylvania, United States, 18940
        • Female Pelvic Health Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Walnut Hill OB/GYN Associates
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • INOVA Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are undergoing surgical treatment for uterine prolapse.

Description

Inclusion Criteria:

  1. Patient with POP-Q C point greater than (-) 1 cm.
  2. Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study.
  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 total hysterectomy.
  5. Prior pelvic prolapse surgery using synthetic mesh.
  6. Pathological PAP in the past year.
  7. Moderate or severe bacterial cervicitis.
  8. Moderate or severe pelvic pain (> 3 on VAS).
  9. Severe morbid obesity (BMI >45).
  10. Temperature > 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment.
  11. Significant cognitive impairment.
  12. Active malignancy other than non-melanoma skin cancer.
  13. Planned surgery (more than a minor one) in the next 30 days.
  14. Patient has a known hypersensitivity to device materials (Nickel, suture material).
  15. Moribund patient or patient with severe or deteriorating damage in critical body systems.
  16. 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.
  17. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects
Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.
Device: NeuGuide™ System
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
Other Names:
  • transvaginal sacrospinous ligament fixation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months
The number of device / procedure related Serious Adverse Events (SAE).
Time Frame: 30 days
Primary safety of surgical implantation as reflected by adverse events
30 days
The number of Serious Adverse Events and Adverse Events.
Time Frame: 12 months
Primary safety of NeuGuide treatment as reflected by adverse events
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean POP-Q C point score from baseline (cm).
Time Frame: one month
Secondary anatomical performance of the NeuGuide treatment
one month
Change in mean POP-Q C point score from baseline (cm).
Time Frame: 6 months
Secondary anatomical performance of the NeuGuide treatment
6 months
Change in mean POP-Q C point score from baseline (cm).
Time Frame: 12 months
Secondary anatomical of the NeuGuide treatment
12 months
Change in mean POP-Q C point score from baseline (cm).
Time Frame: 24 months
Secondary anatomical performance of the NeuGuide treatment outcome
24 months
Change in mean POP-Q C point score from baseline (cm).
Time Frame: 36 months
Secondary anatomical performance of the NeuGuide treatment
36 months
Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.
Time Frame: 36 months
Secondary performance: durability of the NeuGuide treatment
36 months
Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.
Time Frame: 12 months
Secondary symptomatic performance of the NeuGuide treatment
12 months
The time utilization of staff performing the NeuGuide procedure.
Time Frame: one month
Secondary outcome: Cost performance of the procedure
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
Secondary outcome: POP-Q Stage Score.
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
Secondary outcome: POP-Q Stage Score.
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
Secondary outcome: POP-Q Stage Score.
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
Secondary outcome: POP-Q Stage Score.
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
Secondary outcome: POP-Q Stage Score.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pop Medical Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James C Leiter, M.D., Avania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-CLP-0098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data a available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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