Clinical trial NCT00979342: Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
Official title: Interlace Medical Comparative Sedation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Polyps
Keywords: morcellator
hysteroscope
myomectomy
polypectomy
uterine fibroids
uterine polyps
local anesthetic
cervical block
pain management
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
timeFrame: Immediately post treatment
Secondary outcomes:
measure: Subject assessment of most severe post-procedural pain rated on an 11 point scale
timeFrame: Prior to subject discharge from office/day surgery unit
measure: Subject assessment of most severe pain experienced during 48 hours post procedure, rated on an 11 point scale
timeFrame: 48 hours (+ 24 hours) post procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Gynecology Consultants
state: Arizona
city: Boca Raton
country: United States
facility: Florida Woman Care
state: Florida
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Edina
country: United States
facility: Minnesota Gynecology and Surgery
state: Minnesota
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
Study officials:
affiliation: Carolina Women's Research and Wellness Center
name: Andrea Lukes, MD
role: PRINCIPAL_INVESTIGATOR
References: