Uterine Fibroids Clinical Trial
Official title:
MyoSure Hysteroscopic Tissue Removal System Registry Study
Verified date | September 2012 |
Source | Hologic, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | November 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Healthy female between 18 and 65 years of age 2. 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 3. Subject is indicated for myomectomy or polypectomy 4. 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: - All polyps - All Type 0, Type 1 or Type 2 myomas = 6 cm in diameter - Polyps plus Type 0, Type 1 or Type 2 myomas =6 cm in diameter Exclusion Criteria: 1. Subject is pregnant 2. Subject has an IUD at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure 3. Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin 4. Active pelvic inflammatory disease or pelvic/vaginal infection 5. Subject has a known or suspected coagulopathy or bleeding disorder 6. Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction) 7. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hologic, Inc. | Marlborough | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Hologic, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Efficacy | Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatmet procedure | 1 hour post treatment | No |
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. | 1 hour post treatment | No |
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