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

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: Completed
• Conditions: Uterine Prolapse Without Vaginal Wall Prolapse
• Intervention / Treatment: Device: NeuGuide™ System

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	Primary composite performance outcome	12 months
The number of device / procedure related Serious Adverse Events (SAE).	Primary safety of surgical implantation as reflected by adverse events	30 days
The number of Serious Adverse Events and Adverse Events.	Primary safety of NeuGuide treatment as reflected by adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean POP-Q C point score from baseline (cm).	Secondary anatomical performance of the NeuGuide treatment	one month
Change in mean POP-Q C point score from baseline (cm).	Secondary anatomical performance of the NeuGuide treatment	6 months
Change in mean POP-Q C point score from baseline (cm).	Secondary anatomical of the NeuGuide treatment	12 months
Change in mean POP-Q C point score from baseline (cm).	Secondary anatomical performance of the NeuGuide treatment outcome	24 months
Change in mean POP-Q C point score from baseline (cm).	Secondary anatomical performance of the NeuGuide treatment	36 months
Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.	Secondary performance: durability of the NeuGuide treatment	36 months
Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.	Secondary symptomatic performance of the NeuGuide treatment	12 months
The time utilization of staff performing the NeuGuide procedure.	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	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	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	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	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	Secondary outcome: POP-Q Stage Score.	36 months

Collaborators and Investigators

• Sponsor: Pop Medical Solutions
• Investigators: Study Director: James C Leiter, M.D., Avania

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: prolapse; sacrospinous fixation; minimally invasive
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID 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