Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Not Applicable

Completed

• Conditions: Uterine Fibroids; Polyps
• Interventions: Device: Hysteroscopic Morcellator

• Registration Number: NCT00979342
• Lead Sponsor: Hologic, Inc.

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.

Study Timeline

• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Study Start: 2009-11
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Block, 6 injection sites	Hysteroscopic Morcellator	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.
Cervical Block, 2 injection sites	Hysteroscopic Morcellator	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.
Ibuprofen q. 8 hours	Hysteroscopic Morcellator	Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg every 8 hours, for the first 24 hours and then PRN.
Ibuprofen PRN	Hysteroscopic Morcellator	Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.

Primary Outcome Measures

Name	Time	Method
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)	Immediately post treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Minnesota Gynecology and Surgery; 🇺🇸 Edina, Minnesota, United States

Phoenix Gynecology Consultants; 🇺🇸 Phoenix, Arizona, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Florida Woman Care; 🇺🇸 Boca Raton, Florida, United States

Carolina Women's Research and Wellness Center; 🇺🇸 Durham, North Carolina, United States