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The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.
Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrauterine pathology, myomectomy | Experimental | Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoSure Tissue Removal System | Device | The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Efficacy | Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure | 1 hour post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects That Achieve 100% Removal of Target Pathology | Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures. | 1 hour post treatment |
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Inclusion Criteria:
Healthy female between 18 and 65 years of age
Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her
Subject is indicated for myomectomy or polypectomy
Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Evantash | Hologic, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hologic, Inc. | Marlborough | Massachusetts | 01752 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrauterine Pathology, Myomectomy | Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
290 Subjects enrolled. Nine (9) subjects removed from analysis because they did not meet the inclusion criteria. Three (3) subjects removed from analysis because they met the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrauterine Pathology, Myomectomy | Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Procedure Efficacy | Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure | 559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients. | Posted | Mean | 95% Confidence Interval | percent of pathology | 1 hour post treatment |
|
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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 | Intrauterine Pathology, Myomectomy | Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical Trauma | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Mastandrea | Hologic, Inc | 508-263-8772 | Christina.Mastandrea@Hologic.com |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Subjects That Achieve 100% Removal of Target Pathology | Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 hour post treatment |
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|
| 0 |
| 278 |
| 5 |
| 278 |
| Pedal Edema Post-operative | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |