Clinical trial NCT03436979: The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
Official title: The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Uterine Prolapse Without Vaginal Wall Prolapse
Keywords: prolapse
sacrospinous fixation
minimally invasive
Lead sponsor: Pop Medical Solutions
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are undergoing surgical treatment for uterine prolapse.

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 12 months
measure: The number of device / procedure related Serious Adverse Events (SAE).
timeFrame: 30 days
measure: The number of Serious Adverse Events and Adverse Events.
timeFrame: 12 months
Secondary outcomes:
measure: Change in mean POP-Q C point score from baseline (cm).
timeFrame: one month
measure: Change in mean POP-Q C point score from baseline (cm).
timeFrame: 6 months
measure: Change in mean POP-Q C point score from baseline (cm).
timeFrame: 12 months
measure: Change in mean POP-Q C point score from baseline (cm).
timeFrame: 24 months
measure: Change in mean POP-Q C point score from baseline (cm).
timeFrame: 36 months
measure: Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.
timeFrame: 36 months
measure: Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.
timeFrame: 12 months
measure: The time utilization of staff performing the NeuGuide procedure.
timeFrame: one month
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: one month
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 24 months
measure: 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
timeFrame: 36 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Valley Stream
country: United States
facility: South Nassau Community Hospital Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Cleveland
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Newtown
country: United States
facility: Female Pelvic Health Center
state: Pennsylvania
city: Dallas
country: United States
facility: Walnut Hill OB/GYN Associates
state: Texas
city: Falls Church
country: United States
facility: INOVA Women's Hospital
state: Virginia
city: Berlin-Tempelhof
country: Germany
facility: St. Joseph Krankenhaus
city: Berlin-Zehlendorf
country: Germany
facility: Krankenhaus Waldfriede
city: München
country: Germany
facility: Isar Kliniken GmbH
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Avania
name: James C Leiter, M.D.
role: STUDY_DIRECTOR
References: