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Effectiveness of Truclear on Patient Quality of Life

NCT02934789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2018-06-27

No results posted yet for this study

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.

Conditions

  • Heavy Menstrual Bleeding

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • All For Women Healthcare, Illinois

    lead OTHER

Principal Investigators

  • Teresa Tam, MD · All For Women Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-04-30
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934789 on ClinicalTrials.gov