MyoSure Hysteroscopic Tissue Removal System Registry Study
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| City: |
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Marlborough |
| State: |
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Massachusetts |
| Zip Code: |
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01752 |
| Conditions: |
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Uterine Fibroids - Polyps |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01369758 |
| Primary Contact: |
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Principal Investigator
Edward Evantash
Hologic, Inc.
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| Backup Contact: |
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N/A |
| Location Contact: |
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Marlborough, Massachusetts 01752
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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