Interlace Medical Comparative Sedation Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Uterine Fibroids
- Sponsor
- Hologic, Inc.
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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
Outcomes
Primary Outcomes
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
Time Frame: Immediately post treatment
Secondary Outcomes
- Subject assessment of most severe post-procedural pain rated on an 11 point scale(Prior to subject discharge from office/day surgery unit)
- Subject assessment of most severe pain experienced during 48 hours post procedure, rated on an 11 point scale(48 hours (+ 24 hours) post procedure)