Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Completed · Not applicable

Conditions studied: Uterine Fibroids, Polyps

In brief

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.

Key facts

Study ID

NCT00979342

Run by

Hologic, Inc.

People needed

40

Starts

2009-11-01

Expected to finish

2010-07-01

Last updated by the study team

2010-07-23

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Healthy female between the ages of 18 and 65
• 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 a pre-menopausal or peri-menopausal female, either nulliparous or parous
• Subject is indicated for myomectomy or polypectomy for benign pathology, based on hysteroscopic, ultrasound, or saline infused sonogram assessment within 60 days
• 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
• A single Type 0 or Type 1 myoma ≤ 3 cm
• Polyps plus a single Type 0 or Type 1 myoma ≤ 3 cm
• Negative pregnancy test within 48 hours prior to planned index procedure and willing to use reliable birth control for the next 30 days. Reliable birth control is defined as a chemical or barrier method, including an oral contraceptive, injectable contraceptive, or the combination of a spermicide and condoms

You may not qualify if…

• Known or suspected cancer, including breast, endometrial, and ovarian
• Subject has Type 2 myoma
• Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
• Subject has a history of chronic narcotic use
• Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
• Subject with blood borne pathogens-HIV, hepatitis B, CJD, etc.
• Subject plans to become pregnant within the study period
• 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
• 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 unmanaged endocrine disease
• Subject has current or past, acute or chronic psychiatric disorder which, in the opinion of the Investigator, may preclude proper evaluation and follow-up
• Subject has history of auto-immune, inflammatory, or connective tissue disease
• Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
• Uncontrolled hypertension lasting two years or more
• Use of any experimental drug or device within 30 days prior to the screening visit
• The subject has a terminal illness that may prevent the completion of any follow-up assessments
• Any employee or relative of an employee of the Sponsor company or any Investigator site employee or relative of employees working on the study
• 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

Where it is running

• Phoenix Gynecology Consultants — Phoenix, Arizona, United States
• Florida Woman Care — Boca Raton, Florida, United States
• Wayne State University — Detroit, Michigan, United States
• Minnesota Gynecology and Surgery — Edina, Minnesota, United States
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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