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MyoSure Hysteroscopic Tissue Removal System Registry Study

Primary Purpose

Uterine Fibroids, Polyps

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MyoSure Tissue Removal System

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hologic, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrauterine pathology, myomectomy

Arm Description

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

Outcomes

Primary Outcome Measures

Procedure Efficacy

Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01369758

First Posted

November 11, 2010

Last Updated

August 9, 2017

Sponsor

Hologic, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01369758

Brief Title

MyoSure Hysteroscopic Tissue Removal System Registry Study

Official Title

MyoSure Hysteroscopic Tissue Removal System Registry Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hologic, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids, Polyps

Keywords

morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intrauterine pathology, myomectomy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MyoSure Tissue Removal System

Other Intervention Name(s)

Myomectomy procedure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Procedure Efficacy

Description

Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Time Frame

1 hour post treatment

Secondary Outcome Measure Information:

Title

Percentage of Subjects That Achieve 100% Removal of Target Pathology

Description

Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.

Time Frame

1 hour post treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Evantash

Organizational Affiliation

Hologic, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hologic, Inc.

City

Marlborough

State/Province

Massachusetts

ZIP/Postal Code

01752

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

MyoSure Hysteroscopic Tissue Removal System Registry Study

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