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Completed

NCT Number: NCT02934789

Effectiveness of Truclear 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.

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Key information

Conditions

Heavy Menstrual Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

All For Women Healthcare

Chicago, Illinois, 60657, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hysteroscopic myomectomy with Truclear

Procedure

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

Other names: Truclear

Medical Therapy

Drug

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

Other names: oral contraceptive pills, Mirena intrauterine device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

All For Women Healthcare, Illinois

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: HSCMyomecty

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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