Heavy Menstrual BleedingHSCMyomectyNCT02934789
Effectiveness of Truclear on Patient Quality of Life
A study testing Hysteroscopic myomectomy with Truclear and Medical therapy in people with Heavy Menstrual Bleeding, run by All For Women Healthcare, Illinois at 1 site in United States.
Trial summary
This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Hysteroscopic myomectomy with Truclear and Medical therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2018
- 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 21 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills
- Patients with Type 0, 1 or 2 submucosal myomas
Who cannot join
- Pregnant women
- Patients with suspicion of uterine malignancy
- Patients without submucosal fibroid seen during planned hysteroscopic myomectomy
- Patients with active vaginal infection
- Patients with contraindication to hysteroscopic myomectomy
- Patients with cognitive impairment who are unable to provide consent and adequately complete the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life
This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
Read the detailed description
Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Hysteroscopic myomectomy with Truclear, Medical therapy
- Keywords
- submucosal fibroids, heavy menstrual bleeding, quality of life
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic myomectomy with TruclearProcedure or surgery
Also called Truclear
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Medical therapyDrug
Also called oral contraceptive pills, Mirena intrauterine device
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.
| Study group | Role | What they receive |
|---|---|---|
| Study group: surgical arm | Active comparator | Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). Receives: Procedure: Hysteroscopic myomectomy with Truclear |
| Control group: medical arm | Active comparator | Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.
Measured: Two years
Secondary outcomes (1)
Secondary surgical outcomes
Secondary surgical outcomes include estimated blood loss (EBL), operating time (OT), pedal resection time, fluid deficit, total fluid use, pathology report (including total myoma weight), surgical outcome and complications.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy Menstrual BleedingStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- All For Women Healthcare, Illinois
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Teresa Tam, MD, Principal investigator, All For Women Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934789
- Sponsor's protocol ID
- 2015-17
- Acronym
- HSCMyomecty
- Status last verified
- Jun 2018
- First submitted
- 14 Oct 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.
PubMed 20733447
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life
- ClinicalTrials.gov ID
- NCT02934789
- Acronym / sponsor ID
- HSCMyomecty / 2015-17
- Conditions
- Heavy Menstrual Bleeding
- Keywords
- submucosal fibroids, heavy menstrual bleeding, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- All For Women Healthcare, IllinoisUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Oct 2016 (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.
This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
Detailed description
Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: surgical arm | Active comparator | Procedure: Hysteroscopic myomectomy with TruclearHysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). |
| Control group: medical arm | Active comparator | Drug: Medical therapyMedical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills
- Patients with Type 0, 1 or 2 submucosal myomas
Key exclusion criteria (6 listed)
- Pregnant women
- Patients with suspicion of uterine malignancy
- Patients without submucosal fibroid seen during planned hysteroscopic myomectomy
- Patients with active vaginal infection
- Patients with contraindication to hysteroscopic myomectomy
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 myomectomy with TruclearAlso: TruclearHysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). | Procedure or surgery | Study group: surgical arm |
| Medical therapyAlso: oral contraceptive pills, Mirena intrauterine deviceMedical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids. | Drug | Control group: medical arm |
Primary outcome
Quality of life score
Time frame: Two years
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.
1 secondary outcome
Secondary surgical outcomes
Time frame: Two years
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 27 Jun 2018.
- Background: PubMed 20733447Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.
- Individual participant dataSharing planned: Yes
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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.
Teresa Tam, MD principal investigator
All For Women Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic myomectomy with Truclear and Medical therapy in people with Heavy Menstrual Bleeding, run by All For Women Healthcare, Illinois at 1 site 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 2 inclusion and 6 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Quality of life score (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934789, which also lists 1 linked publication.
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 27 Jun 2018.