Uterine FibroidsNCT00979342
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
A study testing Hysteroscopic Morcellator in people with Uterine Fibroids and Polyps, run by Hologic, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Fibroids, Polyps
- What is being tested?
- Hysteroscopic Morcellator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Florida Woman Care
Boca Raton, Florida, 33431
Wayne State University
Detroit, Michigan, 48201
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
Minnesota Gynecology and Surgery
Edina, Minnesota, 55435
Phoenix Gynecology Consultants
Phoenix, Arizona, 85013
About this study
Official title: Interlace Medical Comparative Sedation Study
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.
Read the 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.
- Conditions
- Uterine Fibroids, Polyps
- Being tested
- Hysteroscopic Morcellator
- Keywords
- morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps, local anesthetic, cervical block, pain management
- Medical subject headings
- Leiomyoma, Polyps, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic MorcellatorDevice
Also called MyoSure Hysteroscopic Tissue Removal System, MyoSure Tissue Removal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Hysteroscopic Morcellator |
| Ibuprofen PRN | Experimental | Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN. Receives: Device: Hysteroscopic Morcellator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
Measured: Immediately post treatment
Secondary outcomes (2)
Subject assessment of most severe post-procedural pain rated on an 11 point scale
Measured: 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
Measured: 48 hours (+ 24 hours) post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrea Lukes, MD, Principal investigator, Carolina Women's Research and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979342
- Sponsor's protocol ID
- TMP 200902
- Status last verified
- Jul 2010
- First submitted
- 17 Sep 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interlace Medical Comparative Sedation Study
- ClinicalTrials.gov ID
- NCT00979342
- Acronym / sponsor ID
- TMP 200902
- Conditions
- Uterine Fibroids, Polyps
- Keywords
- morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps, local anesthetic, cervical block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervical Block, 6 injection sites | Experimental | Device: Hysteroscopic MorcellatorSubject 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 | Experimental | Device: Hysteroscopic MorcellatorSubject 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 | Experimental | Device: Hysteroscopic MorcellatorSubjects 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 | Experimental | Device: Hysteroscopic MorcellatorSubjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic MorcellatorAlso: MyoSure Hysteroscopic Tissue Removal System, MyoSure Tissue Removal DeviceThe 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. | Device | Cervical Block, 2 injection sites, Cervical Block, 6 injection sites, Ibuprofen PRN, Ibuprofen q. 8 hours |
Primary outcome
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
Time frame: Immediately post treatment
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lukes, MD principal investigator
Carolina Women's Research and Wellness Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic Morcellator in people with Uterine Fibroids and Polyps, run by Hologic, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10) (time frame: Immediately post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.