Effectiveness of Truclear on Patient Quality of Life

Completed · Not applicable

Conditions studied: Heavy Menstrual Bleeding

In brief

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.

Key facts

Study ID

NCT02934789

Run by

All For Women Healthcare, Illinois

People needed

69

Starts

2014-09-01

Expected to finish

2018-05-01

Last updated by the study team

2018-06-27

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• All For Women Healthcare — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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