Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Leiomyoma

Myofibroma

Polyps

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

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

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.

MyoSure Tissue Removal System

Edward Evantash

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.

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.

MyoSure Hysteroscopic Tissue Removal System Registry Study

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

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

Hologic, Inc.

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

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.

Intrauterine Pathology, Myomectomy

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

290 Subjects enrolled. Nine (9) subjects removed from analysis because they did not meet the inclusion criteria. Three (3) subjects removed from analysis because they met the exclusion criteria.

Christina Mastandrea

559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.

Procedure Efficacy

Percentage of Subjects That Achieve 100% Removal of Target Pathology

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Pain

Uterine Hemorrhage

Pathological Conditions, Anatomical

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

Myomectomy for uterine polyps and/or fibroids occurring in an office setting

Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting

Myomectomy

Edward Evantash, MD

The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.

Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.

HOME Study: Hysteroscopic Office Myomectomy Evaluation

A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

The Journal of Minimally Invasive Gynecology

Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment

Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.

Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)

Myomectomy for uterine polyps and/or fibroids occurring in an office setting

Myomectomy: Removal of fibroids and / or polyps

Treatment, Office Setting, Myomectomy

Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting

Myomectomy: Removal of fibroids and / or polyps

Treatment, Hospital Setting, Myomectomy

Total

Christina Mastandrea / Clinical Research manager

A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).

Percent Reduction in Target Pathology Volume

Percent of Subjects That Achieve 100% Removal of Target Pathology

Subject Self-reported Pain Score Occurring During the Treatment Procedure

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Anti-Arrhythmia Agents

Channel Blockers

Bupivacaine

Ibuprofen

Lidocaine

Subject will receive a cervical block of 1% lidocaine and 0.25% bupivacaine, with injections in the following locations: 2cc at 12:00, 10cc at 3:00, 10 cc at 9:00, 5 cc at 4:00, 5 cc at 8:00, and 5 cc at 6:00.

Subject will receive a cervical block of 1% lidocaine and 0.25% bupivacaine, with injections in the following locations: 10 cc at 4:00, and 10 cc at 8:00.

Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg every 8 hours, for the first 24 hours and then PRN.

Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.

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.

Hysteroscopic Morcellator

Andrea Lukes, MD

The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time intervals between all treatment groups.

Forty subjects will be enrolled in a randomized, controlled study conducted at four physician offices or day surgery settings. Subjects will be randomized 1:1 to a local anesthetic group (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Subsequent to the procedure, subjects will be randomized 1:1 within the local anesthetic group to a post procedure pain management group (Group A or Group B). Subject self-reported pain scores (as rated on an 11 point scale)will be compared at three time points: Immediately post procedure, prior to discharge from the treatment facility, and at 48 hours post procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MyoSure Hysteroscopic Tissue Removal System Registry Study	NCT01369758	Uterine Fibroid... Polyps	MyoSure Tissue ...	18 Years - 65 Years	Hologic, Inc.
HOME Study: Hysteroscopic Office Myomectomy Evaluation	NCT01152112	Uterine Fibroid... Polyps	Myomectomy	18 Years - 55 Years	Hologic, Inc.
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System	NCT00979342	Uterine Fibroid... Polyps	Hysteroscopic M...	18 Years - 65 Years	Hologic, Inc.

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