Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Hologic

Status

Completed

Conditions

Polyps

Uterine Fibroids

Treatments

Device: Hysteroscopic Morcellator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00979342

TMP 200902

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 4 patient groups

Cervical Block, 6 injection sites

Experimental group

Description:

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.

Treatment:

Device: Hysteroscopic Morcellator

Cervical Block, 2 injection sites

Experimental group

Description:

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.

Treatment:

Device: Hysteroscopic Morcellator

Ibuprofen q. 8 hours

Experimental group

Description:

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

Treatment:

Device: Hysteroscopic Morcellator

Ibuprofen PRN

Experimental group

Description:

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