Uterine FibroidsHOMENCT01152112
HOME Study: Hysteroscopic Office Myomectomy Evaluation
A study testing Myomectomy in people with Uterine Fibroids and Polyps, run by Hologic, Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids, Polyps
- What is being tested?
- Myomectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy female between 18 and 55 years of age
- 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 experiencing AUB as confirmed by a symptom raw score of 23 or a calculated symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related Quality of Life (UFS-QOL)
- Subject is indicated for myomectomy or polypectomy for benign appearing pathology, based on a hysteroscopic exam and measured by saline infused sonogram assessment within 30 days of the planned index procedure
- Subject exhibits intrauterine polyps and/or submucous myomas which, in the opinion of the treating physician, are compatible with office-based treatment (e.g. 15 minutes or less of cutting time) using the MyoSure device and meet at least one of the following criteria:
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- One or more polyps, with at least one of the polyps ≥ 1.5 cm and ≤ 3.0 cm diameter and having broad based attachment to the uterine wall.
- Up to two Type 0 or Type 1 myomas with at least one of the myomas being ≥ 1.5 cm and none of the myomas being 3.0 cm diameter
- If the first myoma is 3.0 cm, the second myoma must be ≤ 2.0 cm
- Fundal myomas must be Type 0
- Polyps plus up to two Type 0 or Type I myomas with at least one of the myomas being ≥ 1.5cm and ≤ 3.0 cm
- The subject demonstrates a negative pregnancy test within 48 hours prior to the planned index procedure
- The subject must document a score of 5 or lower on the Pap Smear and Blood Draw scales of the Pain Tolerance Survey
Who cannot join
- Subject has known or suspected cancer, including breast, endometrial, and ovarian
- Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
- The subject has a history of chronic narcotic use
- Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
- Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.
- 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
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- 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 a 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
- Subject has one of the following:
- Type II submucosal myoma
- Type O or Type I submucosal myoma > 3.0 cm
- Fundal Type I myoma
- Highly vascularized myoma as determined by SIS or hysteroscopic examination
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Research Division for Integrated Health Services
Ann Arbor, Michigan, 48106
Boulder Women's Clinic
Boulder, Colorado, 80303
Women's Health Care Practice
Champaign, Illinois, 61820
Complete Healthcare for Women
Columbus, Ohio, 43231
Kulbresh Women's Center
Irmo, South Carolina, 29063
Obstetrics and Gynecology
North Charleston, South Carolina, 29406
Phoenix Gynecology Consultants
Phoenix, Arizona, 85013
Williams, Benavides, Marston, & Kaminski
Raleigh, North Carolina, 27609
Rubino OB/Gyn
West Orange, New Jersey, 07052
About this study
Official title: A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)
The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.
Read the detailed description
Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.
- Conditions
- Uterine Fibroids, Polyps
- Being tested
- Myomectomy
- Keywords
- morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps, office, cost, 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.
MyomectomyDevice
Also called Fibroid removal, Polyp removal
Removal of fibroids and / or polyps
| Study group | Role | What they receive |
|---|---|---|
| Treatment, Office Setting, myomectomy | Experimental | Myomectomy for uterine polyps and/or fibroids occurring in an office setting Receives: Device: Myomectomy |
| Treatment, Hospital Setting, myomectomy | Experimental | Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting Receives: Device: Myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in Target Pathology Volume
Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment
Measured: Three months post treatment
Secondary outcomes (2)
Percent of Subjects That Achieve 100% Removal of Target Pathology
Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.
Measured: Three months post treatment
Subject Self-reported Pain Score Occurring During the Treatment Procedure
Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)
Measured: 1 hour post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Evantash, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152112
- Sponsor's protocol ID
- TMP 2009003
- Acronym
- HOME
- Status last verified
- Aug 2017
- First submitted
- 18 Jun 2010
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The Journal of Minimally Invasive Gynecology
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)
- ClinicalTrials.gov ID
- NCT01152112
- Acronym / sponsor ID
- HOME / TMP 2009003
- Conditions
- Uterine Fibroids, Polyps
- Keywords
- morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids, uterine polyps, office, cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 13 Sep 2017
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 demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.
Detailed description
Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment, Office Setting, myomectomy | Experimental | Device: MyomectomyMyomectomy for uterine polyps and/or fibroids occurring in an office setting |
| Treatment, Hospital Setting, myomectomy | Experimental | Device: MyomectomyMyomectomy for uterine polyps and/or fibroids occurring in a hospital setting |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy female between 18 and 55 years of age
- 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 experiencing AUB as confirmed by a symptom raw score of 23 or a calculated symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related Quality of Life (UFS-QOL)
- Subject is indicated for myomectomy or polypectomy for benign appearing pathology, based on a hysteroscopic exam and measured by saline infused sonogram assessment within 30 days of the planned index procedure
Key exclusion criteria (23 listed)
- Subject has known or suspected cancer, including breast, endometrial, and ovarian
- Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
- The subject has a history of chronic narcotic use
- Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
- Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.
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 |
|---|---|---|
| MyomectomyAlso: Fibroid removal, Polyp removalRemoval of fibroids and / or polyps | Device | Treatment, Hospital Setting, myomectomy, Treatment, Office Setting, myomectomy |
Primary outcome
Percent Reduction in Target Pathology Volume
Time frame: Three months post treatment
Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment
2 secondary outcomes
Percent of Subjects That Achieve 100% Removal of Target Pathology
Time frame: Three months post treatment
Subject Self-reported Pain Score Occurring During the Treatment Procedure
Time frame: 1 hour post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Journal of Minimally Invasive Gynecology
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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.
Edward Evantash, MD study director
Sponsor GmbH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myomectomy in people with Uterine Fibroids and Polyps, run by Hologic, Inc. at 9 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 13 inclusion and 23 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Reduction in Target Pathology Volume (time frame: Three months 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 13 Sep 2017.