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Health Condition(s) or Problem
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Leiomyoma; Uterine Fibroids; Menorrhagia
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Lay Summary
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The primary objective of this study is to establish the effectiveness and confirm the safety
of the VizAblate System in ablating symptomatic uterine fibroids.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- 28 years of age or older
- Regular, consistent menstrual cycles
- Objective evidence of normal ovulatory function
- History of excessive bleeding
- One Menstrual Pictogram score = 120 during a one-month screening period
- Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity
Subscale (SSS) score = 20
- Between 1 and 5 Target Fibroids between 1 cm and 5 cm
- At least one fibroid must indent the endometrium
- Subject is not at material risk for pregnancy.
- Subject is willing to maintain use or non-use of hormonal contraception
- Subject is willing to have uniform maintenance (use or non-use) of any
antifibrinolytic or nonsteroidal anti-inflammatory agents
Exclusion Criteria:
- Subserosal fibroids with bulk symptoms
- Presence of type 0 intracavitary fibroids
- Any Target Fibroid > 5 cm in maximum diameter
- Any fibroid that obstructs access of the VizAblate probe
- Postmenopausal by history
- Desire for current or future fertility
- Hemoglobin < 6 g/dl
- Pregnancy
- Evidence of disorders of hemostasis
- Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable
progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective
progesterone receptor modulator (SPRM)
- Current use of any intrauterine device (IUD) or use of Mirena® intrauterine system
(IUS)
- Use of hormonal medication for management of bleeding
- Evidence for current cervical dysplasia
- Endometrial hyperplasia
- Confirmed abdominal / pelvic malignancy within the previous five years
- Active pelvic infection
- Clinically significant adenomyosis
- Previous surgical, embolizational, or ablative treatment for fibroids or menorrhagia
- Current use of anticoagulant therapy
- Need for emergency surgery to treat fibroid symptoms
- Concomitant intrauterine polyps > 1.0 cm
- Contraindication to MRI
- Renal insufficiency
- Uncontrolled hypertension lasting 2 years or more
- Uterine size > 12 weeks
- One or more treatable fibroids that are calcified
- Chronic pelvic pain
- Presence of an extrauterine pelvic mass
- Presence of a tubal implant for sterilization
- Previous pelvic irradiation
- Endometrial cavity length < 4.5 cm
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Who cannot enter the trial
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Inclusion Criteria:
- 28 years of age or older
- Regular, consistent menstrual cycles
- Objective evidence of normal ovulatory function
- History of excessive bleeding
- One Menstrual Pictogram score = 120 during a one-month screening period
- Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity
Subscale (SSS) score = 20
- Between 1 and 5 Target Fibroids between 1 cm and 5 cm
- At least one fibroid must indent the endometrium
- Subject is not at material risk for pregnancy.
- Subject is willing to maintain use or non-use of hormonal contraception
- Subject is willing to have uniform maintenance (use or non-use) of any
antifibrinolytic or nonsteroidal anti-inflammatory agents
Exclusion Criteria:
- Subserosal fibroids with bulk symptoms
- Presence of type 0 intracavitary fibroids
- Any Target Fibroid > 5 cm in maximum diameter
- Any fibroid that obstructs access of the VizAblate probe
- Postmenopausal by history
- Desire for current or future fertility
- Hemoglobin < 6 g/dl
- Pregnancy
- Evidence of disorders of hemostasis
- Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable
progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective
progesterone receptor modulator (SPRM)
- Current use of any intrauterine device (IUD) or use of Mirena® intrauterine system
(IUS)
- Use of hormonal medication for management of bleeding
- Evidence for current cervical dysplasia
- Endometrial hyperplasia
- Confirmed abdominal / pelvic malignancy within the previous five years
- Active pelvic infection
- Clinically significant adenomyosis
- Previous surgical, embolizational, or ablative treatment for fibroids or menorrhagia
- Current use of anticoagulant therapy
- Need for emergency surgery to treat fibroid symptoms
- Concomitant intrauterine polyps > 1.0 cm
- Contraindication to MRI
- Renal insufficiency
- Uncontrolled hypertension lasting 2 years or more
- Uterine size > 12 weeks
- One or more treatable fibroids that are calcified
- Chronic pelvic pain
- Presence of an extrauterine pelvic mass
- Presence of a tubal implant for sterilization
- Previous pelvic irradiation
- Endometrial cavity length < 4.5 cm
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What will happen
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Device; VizAblate System; VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.; VizAblate treatment
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Primary aim
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Mean percentage change in target fibroid perfused volume
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Secondary Aim
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Number of adverse events; procedure through 12 mo; Yes; Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.; Percentage reduction in Menstrual Pictogram score; baseline through 12 months; No; Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire; baseline through 12 months; No; Rate of surgical reintervention for menorrhagia; through 12 months; No; Return to normal daily activity; 2 weeks or until returned to normal activity; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London, Birmingham, Haywards Heath, Bradford
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