Interlace Medical Comparative Sedation Study

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