Effectiveness of Truclear on Patient Quality of Life

Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02934789

Acronym

HSCMyomecty

Enrollment

Registered

2016-10-17

Start date

2014-09-30

Completion date

2018-05-31

Last updated

2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Menstrual Bleeding

Keywords

submucosal fibroids, heavy menstrual bleeding, quality of life

Brief 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. 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.

Interventions

PROCEDUREHysteroscopic myomectomy with Truclear

Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).

DRUGMedical therapy

Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of life score	Two years	Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.

Secondary

Measure	Time frame	Description
Secondary surgical outcomes	Two years	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026