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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuGuide™ System | Device | The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Primary composite performance outcome | 12 months |
| The number of device / procedure related Serious Adverse Events (SAE). | Primary safety of surgical implantation as reflected by adverse events | 30 days |
| The number of Serious Adverse Events and Adverse Events. | Primary safety of NeuGuide treatment as reflected by adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment | one month |
| Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment |
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Inclusion Criteria:
Exclusion Criteria:
Must have uterine prolapse
Subjects who are undergoing surgical treatment for uterine prolapse.
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| Name | Affiliation | Role |
|---|---|---|
| James C Leiter, M.D. | Avania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States | ||
| Holy Cross Hospital |
There is no plan to make individual participant data a available to other researchers.
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| 6 months |
| Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical of the NeuGuide treatment | 12 months |
| Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment outcome | 24 months |
| Change in mean POP-Q C point score from baseline (cm). | Secondary anatomical performance of the NeuGuide treatment | 36 months |
| Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence. | Secondary performance: durability of the NeuGuide treatment | 36 months |
| Number of subjects in whom the primary symptomatic reason for repair of prolapse persists. | Secondary symptomatic performance of the NeuGuide treatment | 12 months |
| The time utilization of staff performing the NeuGuide procedure. | Secondary outcome: Cost performance of the procedure | one month |
| 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 | Secondary outcome: POP-Q Stage Score. | Baseline |
| 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 | Secondary outcome: POP-Q Stage Score. | one month |
| 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 | Secondary outcome: POP-Q Stage Score. | 12 months |
| 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 | Secondary outcome: POP-Q Stage Score. | 24 months |
| 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 | Secondary outcome: POP-Q Stage Score. | 36 months |
| Fort Lauderdale |
| Florida |
| 33364 |
| United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11220 | United States |
| South Nassau Community Hospital Cancer Center | Valley Stream | New York | 11580 | United States |
| Cleveland Clinic Cleveland | Cleveland | Ohio | 44195 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18103 | United States |
| Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | United States |
| Walnut Hill OB/GYN Associates | Dallas | Texas | 75231 | United States |
| INOVA Women's Hospital | Falls Church | Virginia | 22046 | United States |
| Krankenhaus Waldfriede | Berlin-Zehlendorf | 14163 | Germany |
| Isar Kliniken GmbH | München | Germany |
| St. Joseph Krankenhaus | Tempelhof | Germany |
| Soroka Medical Center | Beersheba | Israel |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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