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View Clinical Trial (Medical Research Study)
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Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System - NCT00979342-27713 (Clinical Trial 331433)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331433.aspx
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27713 |
| Conditions: |
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Uterine Fibroids - Polyps |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Carolina Women's Research and Wellness Center
Durham, NC 27713
United States
Primary Contact:
Andrea Lukes, MD
Email: andrealukes@cwrwc.com
Phone: 919-251-9223
Secondary Contact:
Jennifer A Sahatjian, Psy.D.
Email: jennifer@interlacemedical.com
Phone: 508-875-1343 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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