8798 Pressure-Induced Fibroid Ischemia: First-in-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Fibroids

Abstract

Study Objective Assessment of feasibility of use of a novel fibroid treatment device intended to cause fibroid infarction by increasing intra-tumoral pressure. Design Prospective, single-arm, single-center. Follow up duration – 12 months post-procedure. Setting Subjects in dorsal lithotomy position; arms secured at the sides, shoulder pads in Trendelenburg position during laparoscopy. Surgeon on the subject's left, assistant on the subject's right; facing subject's legs. Laparoscopic tower at the midline of subject's legs. Patients or Participants Sixteen 30–50-year–old pre-menopausal black women indicated for hysterectomy with 2-6–cm type-2-, 3-, 4-, 5-, 6-, or 2-5-fibroids. Main exclusion criteria: prior myomectomy or surgical or minimally-invasive fibroid treatment, known/suspected pregnancy, pregnancy intent, prior pelvic surgery, ongoing anticoagulant therapy, life-threatening condition, contraindication for magnetic resonance imaging with gadolinium contrast. Eleven subjects completed the follow-up. Interventions The novel Empress fibroid treatment system comprises two handheld devices (OrbiTal, OrbiTight), a titanium ring, and a size-0 absorbable suture. OrbiTal was inserted into the abdominal cavity and a suture was passed around a fibroid. OrbiTight carrying the titanium ring was inserted thereafter, the suture was threaded through the ring, tightened, crimped, and left on the uterus outer surface. Multiple sutures could be placed. Measurements and Main Results Uterine and fibroid characteristics were calculated from fat-suppressed T1-weighted coronal, sagittal, and transverse planes on gadolinium-enhanced magnetic resonance images 1 day and 1,3, 6, and 12 months after the procedure. At 3 months, fibroid volume decreased by 36.3% (P=.002) and continued to decrease until the 12-month follow-up (60.4%; P=.008). There were no failed procedures. Improvement was observed at 3 months post-procedure in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire. Serious adverse events, unanticipated risks were not reported. Conclusion Initial assessment of the device supports feasibility of the approach for fibroid treatment, does not reveal safety concerns. Assessment of feasibility of use of a novel fibroid treatment device intended to cause fibroid infarction by increasing intra-tumoral pressure. Prospective, single-arm, single-center. Follow up duration – 12 months post-procedure. Subjects in dorsal lithotomy position; arms secured at the sides, shoulder pads in Trendelenburg position during laparoscopy. Surgeon on the subject's left, assistant on the subject's right; facing subject's legs. Laparoscopic tower at the midline of subject's legs. Sixteen 30–50-year–old pre-menopausal black women indicated for hysterectomy with 2-6–cm type-2-, 3-, 4-, 5-, 6-, or 2-5-fibroids. Main exclusion criteria: prior myomectomy or surgical or minimally-invasive fibroid treatment, known/suspected pregnancy, pregnancy intent, prior pelvic surgery, ongoing anticoagulant therapy, life-threatening condition, contraindication for magnetic resonance imaging with gadolinium contrast. Eleven subjects completed the follow-up. The novel Empress fibroid treatment system comprises two handheld devices (OrbiTal, OrbiTight), a titanium ring, and a size-0 absorbable suture. OrbiTal was inserted into the abdominal cavity and a suture was passed around a fibroid. OrbiTight carrying the titanium ring was inserted thereafter, the suture was threaded through the ring, tightened, crimped, and left on the uterus outer surface. Multiple sutures could be placed. Uterine and fibroid characteristics were calculated from fat-suppressed T1-weighted coronal, sagittal, and transverse planes on gadolinium-enhanced magnetic resonance images 1 day and 1,3, 6, and 12 months after the procedure. At 3 months, fibroid volume decreased by 36.3% (P=.002) and continued to decrease until the 12-month follow-up (60.4%; P=.008). There were no failed procedures. Improvement was observed at 3 months post-procedure in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire. Serious adverse events, unanticipated risks were not reported. Initial assessment of the device supports feasibility of the approach for fibroid treatment, does not reveal safety concerns.