MyoSure Hysteroscopic Tissue Removal System Registry Study

Uterine Fibroids Clinical Trial

Official title:

MyoSure Hysteroscopic Tissue Removal System Registry Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01369758
• Other study ID #: TMP 200905
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 11, 2010
• Last updated: November 20, 2012
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2012
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Polyps
• Uterine Fibroids

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Hologic, Inc.	Marlborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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