Interlace Medical Comparative Sedation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cervical Block, 6 injection sites
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.
干预措施: Hysteroscopic Morcellator (Device)
Cervical Block, 2 injection sites
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.
干预措施: Hysteroscopic Morcellator (Device)
Ibuprofen q. 8 hours
Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg every 8 hours, for the first 24 hours and then PRN.
干预措施: Hysteroscopic Morcellator (Device)
Ibuprofen PRN
Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.
干预措施: Hysteroscopic Morcellator (Device)
结局指标
主要结局
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
时间窗: Immediately post treatment
次要结局
- 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)