MyoSure Hysteroscopic Tissue Removal System Registry Study

NCT01369758 | Completed Results

• 1 other identifier: TMP 200905
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids; Polyps

Keywords

morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps

Outcome Measures

Primary Outcomes (1)

• Procedure Efficacy

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

  1 hour post treatment

Secondary Outcomes (1)

• Percentage of Subjects That Achieve 100% Removal of Target Pathology

  1 hour post treatment

Study Arms (1)

Intrauterine pathology, myomectomy

EXPERIMENTAL

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

Device: MyoSure Tissue Removal System

Interventions

MyoSure Tissue Removal System DEVICE

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.

Also known as: Myomectomy procedure

Intrauterine pathology, myomectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (1)

Hologic, Inc.

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Leiomyoma; Polyps

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christina Mastandrea
• Organization: Hologic, Inc

Christina.Mastandrea@Hologic.com

508-263-8772

Study Officials

• Edward Evantash

  Hologic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: June 9, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)