comparative sedation study of the myosure hysteroscopic tissue removal system

Conditions: Uterine Fibroids; Polyps

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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

Keywords: morcellator hysteroscope myomectomy polypectomy uterine fibroids uterine polyps local anesthetic cervical block pain management