Effectiveness of Truclear on Patient Quality of Life (HSCMyomecty)

June 26, 2018 updated by: All For Women Healthcare, Illinois

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60657
        • All For Women Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group: surgical arm
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Procedure: Hysteroscopic myomectomy with Truclear
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Other Names:
  • Truclear
Active Comparator: Control group: medical arm
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids
Drug: Medical therapy
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.
Other Names:
  • oral contraceptive pills, Mirena intrauterine device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary surgical outcomes
Time Frame: 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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All For Women Healthcare, Illinois

Collaborators

Medtronic

Investigators

  • Principal Investigator: Teresa Tam, MD, All For Women Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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