NCT02934789

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: All For Women Healthcare, Illinois · Academic / Other
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
PROCEDURE	Hysteroscopic myomectomy with Truclear	Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
DRUG	Medical therapy	Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-04-01
• Completion: 2018-05-01
• First posted: 2016-10-17
• Last updated: 2018-06-27

Locations

1 site across 1 country: United States