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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group: surgical arm | Active Comparator | Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). |
|
| Control group: medical arm | Active Comparator | Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopic myomectomy with Truclear | Procedure | Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Tam, MD | All For Women Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All For Women Healthcare | Chicago | Illinois | 60657 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20733447 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2019 | |
| Reset | Aug 14, 2019 | |
| Release | Feb 27, 2023 | |
| Reset | Mar 23, 2023 | |
| Release | Feb 16, 2025 | |
| Reset | Mar 5, 2025 | |
| Release | May 3, 2025 | |
| Reset | May 21, 2025 | |
| Release | Oct 1, 2025 | |
| Reset | Oct 27, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2019 | Aug 14, 2019 | |||
| Feb 27, 2023 |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Medical therapy | Drug | Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids. |
|
|
| Mar 23, 2023 |
| Feb 16, 2025 | Mar 5, 2025 |
| May 3, 2025 | May 21, 2025 |
| Oct 1, 2025 | Oct 27, 2025 |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |