The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
NCT ID: NCT03436979
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2018-01-01
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects
Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.
NeuGuide™ System
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
Interventions
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NeuGuide™ System
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
36 Years
84 Years
FEMALE
No
Sponsors
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Pop Medical Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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James C Leiter, M.D.
Role: STUDY_DIRECTOR
Avania
Locations
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MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Mount Auburn Hospital
Cambridge, Massachusetts, United States
Maimonides Medical Center
Brooklyn, New York, United States
South Nassau Community Hospital Cancer Center
Valley Stream, New York, United States
Cleveland Clinic Cleveland
Cleveland, Ohio, 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
Krankenhaus Waldfriede
Berlin-Zehlendorf, , Germany
Isar Kliniken GmbH
München, , Germany
St. Joseph Krankenhaus
Tempelhof, , Germany
Soroka Medical Center
Beersheba, , Israel
Countries
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Other Identifiers
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06-CLP-0098
Identifier Type: -
Identifier Source: org_study_id
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