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This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms.
The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTAâ„¢ system, under normal clinical conditions, and document its safety and technical reliability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genesys HTA | Other | Genesys HTA Endometrial Ablation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genesys HTA | Device | Genesys HTA Endometrial Ablation |
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| Measure | Description | Time Frame |
|---|---|---|
| Burn Rate | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Malfunctions | A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit. |
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Inclusion Criteria:
Exclusion Criteria:
All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bowman, M.D. | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch | San Diego | California | 92123 | United States | ||
| Christiana Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Genesys HTA | Genesys HTA Endometrial Ablation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Day 1 |
| Serious Adverse Device Effect (SADE) | A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune. | Day 1 |
| Newark |
| Delaware |
| 19718 |
| United States |
| Shelnutt Obstetrics and Gynecology | Athens | Georgia | 30606 | United States |
| Health South Surgecenter of Louisville | Louisville | Kentucky | 40207 | United States |
| Wayne State University Physician Group | Southfield | Michigan | 48034 | United States |
| Seven Hills OB GYN Associates | Cincinnati | Ohio | 45201 | United States |
| Complete Healthcare for Women | Columbus | Ohio | 43213 | United States |
| Associates in Women's Healthcare | Philadelphia | Pennsylvania | 19115 | United States |
| Schuykill Medical Center South | Pottsville | Pennsylvania | 17901 | United States |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | United States |
| State of Franklin Healthcare Associates | Johnson City | Tennessee | 37604 | United States |
| Associates in Obstetrics and Gynecology | Bedford | Texas | 76021 | United States |
| Central Womens Care PA | Dallas | Texas | 75231 | United States |
| Doreen Moser, DO | Grapevine | Texas | 76051 | United States |
| MacArthur OBGYN | Irving | Texas | 75062 | United States |
| Personalized Women's Healthcare | Plano | Texas | 75093 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| Old Farm Obstetrics and Gynecology | Salt Lake City | Utah | 84107 | United States |
| Milwaukee ObGyn | Milwaukee | Wisconsin | 53221 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Genesys HTA | Genesys HTA Endometrial Ablation Genesys HTA: Genesys HTA Endometrial Ablation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Burn Rate | Posted | Number | participants | Day 1 |
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| Secondary | Technical Malfunctions | A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit. | 992 patients = ITT population | Posted | Number | 95% Confidence Interval | percent of participants | Day 1 |
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| Secondary | Serious Adverse Device Effect (SADE) | A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune. | 992 - Intent-To-Treat (ITT) population | Posted | Number | number of participants | Day 1 | participants | participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genesys HTA | Genesys HTA Endometrial Ablation | 1 | 992 | 3 | 992 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn | Reproductive system and breast disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Non-Significant Burn | Reproductive system and breast disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meaghan Wilk | Boston Scientific | 5086834113 | wilkm@bsci.com |
| 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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