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The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
This is a single-arm, multi-center study with three years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vapor endometrial ablation | Experimental | endometrial ablation using the AEGEA Vapor System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEGEA Vapor System(TM) | Device | vapor endometrial ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Reduction of menstrual blood loss | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness Endpoint | Quality of Life | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Levie, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Fertility and Women's Health | New Britain | Connecticut | 06051 | United States | ||
| Clinical Associates of Orlando, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33603496 | Derived | Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 8, 2018 | |
| Reset | Feb 5, 2018 |
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| Orlando |
| Florida |
| 32801 |
| United States |
| Visions Clinical Research | Wellington | Florida | 33414 | United States |
| Rosemark WomenCares Specialists | Idaho Falls | Idaho | 83404 | United States |
| The Advanced Gynecologic Surgery Institute | Naperville | Illinois | 60173 | United States |
| Basinksi, LLC | Newburgh | Indiana | 47630 | United States |
| Minnesota Gynecology & Surgery | Edina | Minnesota | 55435 | United States |
| Mercy Hospital | St Louis | Missouri | 63141 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Carolina Women's Research and Wellness Center/OB-GYN | Durham | North Carolina | 27713 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Baylor All Saints | Fort Worth | Texas | 76104 | United States |
| Department of Obstetrics and Gynecology | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hospital Universitario de la Universidad Autonoma de Nuevo Leon | Monterrey | N.l. | Mexico |
| Isala Klinieken | Zwolle | Overijissel | 8025 AB | Netherlands |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 8, 2018 | Feb 5, 2018 |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
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