MyoSure Hysteroscopic Tissue Removal System Registry Study

Hologic

Status: Completed

Conditions: Polyps; Uterine Fibroids

Treatments: Device: MyoSure Tissue Removal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369758

TMP 200905

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 290 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 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
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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290 participants in 1 patient group

Intrauterine pathology, myomectomy

Experimental group

Description:

Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.

Treatment:

Device: MyoSure Tissue Removal System