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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 : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pop Medical Solutions

Tracking Information
First Submitted Date January 23, 2018
First Posted Date February 19, 2018
Last Update Posted Date August 28, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2019)
  • 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
  • The number of device / procedure related Serious Adverse Events (SAE). [ Time Frame: 30 days ]
    Primary safety of surgical implantation as reflected by adverse events
  • The number of Serious Adverse Events and Adverse Events. [ Time Frame: 12 months ]
    Primary safety of NeuGuide treatment as reflected by adverse events
Original Primary Outcome Measures
 (submitted: February 8, 2018)
  • The number of patients with POP-Q C point is > 0 cm, the patient is satisfied with the outcome of the vaginal colpopexy performed using the NeuGuide™device, and there is no further surgical therapy for uterine prolapse. [ Time Frame: 12 months ]
    Primary composite performance outcome
  • The number of device / procedure related Serious Adverse Events (SAE). [ Time Frame: 30 days ]
    Primary safety of surgical implantation as reflected by adverse events
  • The number of Serious Adverse Events and Adverse Events. [ Time Frame: 12 months ]
    Primary safety of NeuGuide treatment as reflected by adverse events
Change History Complete list of historical versions of study NCT03436979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 5, 2019)
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: one month ]
    Secondary anatomical performance of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 6 months ]
    Secondary anatomical performance of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 12 months ]
    Secondary anatomical of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 24 months ]
    Secondary anatomical performance of the NeuGuide treatment outcome
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 36 months ]
    Secondary anatomical performance of the NeuGuide treatment
  • Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence. [ Time Frame: 36 months ]
    Secondary performance: durability of the NeuGuide treatment
  • 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
  • The time utilization of staff performing the NeuGuide procedure. [ Time Frame: one month ]
    Secondary outcome: Cost performance of the procedure
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: February 8, 2018)
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 30 days ]
    Secondary anatomical performance of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 6 months ]
    Secondary anatomical performance of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 12 months ]
    Secondary anatomical of the NeuGuide treatment
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 24 months ]
    Secondary anatomical performance of the NeuGuide treatment outcome
  • Change in mean POP-Q C point score from baseline (cm). [ Time Frame: 36 months ]
    Secondary anatomical performance of the NeuGuide treatment
  • Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence. [ Time Frame: 3 years ]
    Secondary performance: durability of the NeuGuide treatment
  • 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
  • The time utilization of staff performing the NeuGuide procedure. [ Time Frame: 30 days ]
    Secondary outcome: Cost performance of the procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who are undergoing surgical treatment for uterine prolapse.
Condition Uterine Prolapse Without Vaginal Wall Prolapse
Intervention Device: NeuGuide™ System
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
Other Name: transvaginal sacrospinous ligament fixation
Study Groups/Cohorts Subjects
Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.
Intervention: Device: NeuGuide™ System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 8, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2024
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Must have uterine prolapse
Ages 36 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Germany,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03436979
Other Study ID Numbers 06-CLP-0098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data a available to other researchers.
Responsible Party Pop Medical Solutions
Study Sponsor Pop Medical Solutions
Collaborators Not Provided
Investigators
Study Director: James C Leiter, M.D. MAXIS Medical
PRS Account Pop Medical Solutions
Verification Date August 2019