N/A
Completed N=290
MyoSure Hysteroscopic Tissue Removal System Registry Study
Source: ClinicalTrials.gov NCT01369758 ↗Enrolled (actual)
290
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Procedure Efficacy — 95.4 percent of pathology
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Efficacy |
95.4 | — |
| SECONDARY Percentage of Subjects That Achieve 100% Removal of Target Pathology |
74.6 | — |
Eligibility Criteria
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:
- 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
- Subject is pregnant
- Subject has an Intrauterine Device (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
- Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
- Active pelvic inflammatory disease or pelvic/vaginal infection
- Subject has a known or suspected coagulopathy or bleeding disorder
- Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
- 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
Data sourced from ClinicalTrials.gov (NCT01369758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.