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

Active, not recruiting

• Conditions: Uterine Prolapse Without Vaginal Wall Prolapse
• Interventions: Device: NeuGuide™ System

• Registration Number: NCT03436979
• Lead Sponsor: Pop Medical Solutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-19
• Primary Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects	NeuGuide™ System	Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Cleveland Clinic Cleveland; 🇺🇸 Cleveland, Ohio, United States

St. Joseph Krankenhaus; 🇩🇪 Berlin-Tempelhof, Germany

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

MedStar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

Mount Auburn Hospital; 🇺🇸 Cambridge, Massachusetts, United States

South Nassau Community Hospital Cancer Center; 🇺🇸 Valley Stream, New York, United States

The Institute for Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States

Female Pelvic Health Center; 🇺🇸 Newtown, Pennsylvania, United States

Walnut Hill OB/GYN Associates; 🇺🇸 Dallas, Texas, United States

INOVA Women's Hospital; 🇺🇸 Falls Church, Virginia, United States

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Krankenhaus Waldfriede; 🇩🇪 Berlin-Zehlendorf, Germany

Isar Kliniken GmbH; 🇩🇪 München, Germany

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States