Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

NCT00979342 | Completed

• 1 other identifier: TMP 200902
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Uterine Fibroids; Polyps

Keywords

morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps; local anesthetic; cervical block; pain management

Outcome Measures

Primary Outcomes (1)

• Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)

  Immediately post treatment

Secondary Outcomes (2)

• 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

Study Arms (4)

Cervical Block, 6 injection sites

EXPERIMENTAL

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

Cervical Block, 2 injection sites

EXPERIMENTAL

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

Ibuprofen q. 8 hours

EXPERIMENTAL

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

Ibuprofen PRN

EXPERIMENTAL

Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.

Device: Hysteroscopic Morcellator

Interventions

Hysteroscopic Morcellator DEVICE

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.

Also known as: MyoSure Hysteroscopic Tissue Removal System, MyoSure Tissue Removal Device

Cervical Block, 2 injection sites; Cervical Block, 6 injection sites; Ibuprofen PRN; Ibuprofen q. 8 hours

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (5)

Phoenix Gynecology Consultants

Phoenix, Arizona, 85013, United States

Location

Florida Woman Care

Boca Raton, Florida, 33431, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Minnesota Gynecology and Surgery

Edina, Minnesota, 55435, United States

Location

Carolina Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Leiomyoma; Polyps; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Andrea Lukes, MD

  Carolina Women's Research and Wellness Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

US (5)