NCT02934789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

October 14, 2016

Last Update Submit

June 26, 2018

Conditions

Heavy Menstrual Bleeding

Keywords

submucosal fibroidsheavy menstrual bleedingquality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life score

    Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.

    Two years

Secondary Outcomes (1)

  • Secondary surgical outcomes

    Two years

Study Arms (2)

Study group: surgical arm

ACTIVE COMPARATOR

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

Procedure: Hysteroscopic myomectomy with Truclear

Control group: medical arm

ACTIVE COMPARATOR

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

Drug: Medical therapy

Interventions

Hysteroscopic myomectomy with TruclearPROCEDURE

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

Also known as: Truclear
Study group: surgical arm
Medical therapyDRUG

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

Also known as: oral contraceptive pills, Mirena intrauterine device
Control group: medical arm

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All For Women Healthcare

Chicago, Illinois, 60657, United States

Location

Related Publications (1)

  • Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.

    PMID: 20733447BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Teresa Tam, MD

    All For Women Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

September 1, 2014

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

Locations

US(1)