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

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ClinicalTrials.gov Identifier: NCT03436979
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Uterine Prolapse Without Vaginal Wall Prolapse Device: NeuGuide™ System

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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 Name: transvaginal sacrospinous ligament fixation




Primary Outcome Measures :
  1. 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

  2. The number of device / procedure related Serious Adverse Events (SAE). [ Time Frame: 30 days ]
    Primary safety of surgical implantation as reflected by adverse events

  3. The number of Serious Adverse Events and Adverse Events. [ Time Frame: 12 months ]
    Primary safety of NeuGuide treatment as reflected by adverse events


Secondary Outcome Measures :
  1. Change in mean POP-Q C point score from baseline (cm). [ Time Frame: one month ]
    Secondary anatomical performance of the NeuGuide treatment

  2. Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 6 months ]
    Secondary anatomical performance of the NeuGuide treatment

  3. Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 12 months ]
    Secondary anatomical of the NeuGuide treatment

  4. Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 24 months ]
    Secondary anatomical performance of the NeuGuide treatment outcome

  5. Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 36 months ]
    Secondary anatomical performance of the NeuGuide treatment

  6. Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence. [ Time Frame: 36 months ]
    Secondary performance: durability of the NeuGuide treatment

  7. 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

  8. The time utilization of staff performing the NeuGuide procedure. [ Time Frame: one month ]
    Secondary outcome: Cost performance of the procedure

  9. 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.

  10. 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.

  11. 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. 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.

  13. 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.



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Ages Eligible for Study:   36 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must have uterine prolapse
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are undergoing surgical treatment for uterine prolapse.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436979


Contacts
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Contact: Deborah Garner, M.B.A. +1-215-940-8178 debbie@pop-medical.com
Contact: Kathleen Marshall, M.A. +49-69-2400-3626 MaxisOperations@maxismedical.com

Locations
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United States, District of Columbia
MedStar Health Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Patricia Tanjutco, M.D.    202-877-5811    Patricia.Tanjuctco@medstar.net   
Principal Investigator: Andrew I Sokol, M.D.         
Sub-Investigator: Robert E Gutman, M.D.         
Sub-Investigator: Cheryl B Iglesia, M.D.         
Sub-Investigator: Amy Josphine Park, M.D.         
Sub-Investigator: Lee Ann Richter, M.D.         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33364
Contact: Janice Schuck    954-489-4755    Janice.schuck@holy-cross.com   
Contact: Wilson Burke    954-229-8575    Wilson.Burke@holy-cross.com   
Principal Investigator: G. Willy Davila, M.D.         
Sub-Investigator: Anele Ramia Manfredini, M.D.         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Calvin Killingbeck    954-659-6247    killinc@ccf.org   
Principal Investigator: Eric Hurtado, M.D.         
Sub-Investigator: Jeffrey Schachar, M.D.         
United States, Massachusetts
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen Rogers    617-354-5452    krogers2@mah.harvard.edu   
Principal Investigator: Peter L Rosenblatt, MD         
Sub-Investigator: Katherine Hanaway, MD         
Sub-Investigator: Eman Elkadry, MD         
Sub-Investigator: Anthony DiSciullo, MD         
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11220
Contact: Ellison Mellor    718-283-7927    emellor@maimonidesmed.org   
Principal Investigator: Allison Polland, MD         
South Nassau Community Hospital Cancer Center Recruiting
Valley Stream, New York, United States, 11580
Contact: Alexandra Gutman    516-763-7821    mailto:Alexandra.Gutman@snch.org   
Principal Investigator: Alan Garely, M.D.         
Sub-Investigator: Salma Rahimi, M.D.         
United States, Ohio
Cleveland Clinic Cleveland Recruiting
Cleveland, Ohio, United States, 44195
Contact: Annette Graham, RN    216-445-2597    grahama2@ccf.org   
Contact: Ly Pung, RN    216.445.2494    pungl@ccf.org   
Principal Investigator: Marie Paraiso, M.D.         
Sub-Investigator: Cecile Unger, M.D.         
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Eileen Taff    610-730-2502    etaff@fpminstitute.com   
Sub-Investigator: Miles Murphy, M.D.         
Principal Investigator: Vincente Lucente, M.D.         
Sub-Investigator: Jessica Bao An Ton, M.D.         
Sub-Investigator: Valerie Schissler, M.S.N., C.R.N.P.         
Female Pelvic Health Center Recruiting
Newtown, Pennsylvania, United States, 18940
Contact: Kristi Mahan, PA-C    215-504-8900    kmahan@fphcenter.com   
Contact: Stephanie Molden, Dr.    215-504-8900    smolden@fphcenter.com   
United States, Texas
Walnut Hill OB/GYN Associates Recruiting
Dallas, Texas, United States, 75231
Contact: John D Bertrand, MD    214-363-7801      
Contact: Lora Gantt    214-363-7801    lorapaige@hotmail.com   
United States, Virginia
INOVA Women's Hospital Recruiting
Falls Church, Virginia, United States, 22046
Contact: Megan Lively    703-776-7888    Megan.Lively@inova.org   
Principal Investigator: S. Abbas Shobieri, M.D.         
Sponsors and Collaborators
Pop Medical Solutions
Investigators
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Study Director: James C Leiter, M.D. MAXIS Medical

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Responsible Party: Pop Medical Solutions
ClinicalTrials.gov Identifier: NCT03436979     History of Changes
Other Study ID Numbers: 06-CLP-0098
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data a available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pop Medical Solutions:
prolapse
sacrospinous fixation
minimally invasive

Additional relevant MeSH terms:
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Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse