Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System - Full Text View

Sponsor:	Hologic, Inc.
Information provided by:	Hologic, Inc.
ClinicalTrials.gov Identifier:	NCT00979342

Purpose

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.

Condition	Intervention
Uterine Fibroids Polyps	Device: Hysteroscopic Morcellator

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Interlace Medical Comparative Sedation Study

Resource links provided by NLM:

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:

Subject tolerance of procedure-related pain rated on an 11 point scale (0-10) [ Time Frame: Immediately post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject assessment of most severe post-procedural pain rated on an 11 point scale [ Time Frame: Prior to subject discharge from office/day surgery unit ] [ Designated as safety issue: No ]
Subject assessment of most severe pain experienced during 48 hours post procedure, rated on an 11 point scale [ Time Frame: 48 hours (+ 24 hours) post procedure ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	November 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Device: Hysteroscopic Morcellator The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. Other Names: MyoSure Hysteroscopic Tissue Removal System MyoSure Tissue Removal Device
Experimental: 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.	Device: Hysteroscopic Morcellator The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. Other Names: MyoSure Hysteroscopic Tissue Removal System MyoSure Tissue Removal Device
Experimental: 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.	Device: Hysteroscopic Morcellator The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. Other Names: MyoSure Hysteroscopic Tissue Removal System MyoSure Tissue Removal Device
Experimental: Ibuprofen PRN Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.	Device: Hysteroscopic Morcellator The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle. Other Names: MyoSure Hysteroscopic Tissue Removal System MyoSure Tissue Removal Device

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979342

Locations

United States, Arizona
Phoenix Gynecology Consultants
Phoenix, Arizona, United States, 85013
United States, Florida
Florida Woman Care
Boca Raton, Florida, United States, 33431
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Minnesota Gynecology and Surgery
Edina, Minnesota, United States, 55435
United States, North Carolina
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States, 27713

Sponsors and Collaborators

Hologic, Inc.

Investigators

Principal Investigator:

Andrea Lukes, MD

Carolina Women's Research and Wellness Center

More Information

No publications provided

Responsible Party:	John Vozella, V.P Clinical & Regulatory Affairs, Interlace Medical, Inc,
ClinicalTrials.gov Identifier:	NCT00979342 History of Changes
Other Study ID Numbers:	TMP 200902
Study First Received:	September 17, 2009
Last Updated:	July 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Hologic, Inc.:

morcellator
hysteroscope
myomectomy
polypectomy
uterine fibroids

uterine polyps
local anesthetic
cervical block
pain management

Additional relevant MeSH terms:

Leiomyoma
Myofibroma
Polyps
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Pathological Conditions, Anatomical
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012