Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

• Percentage of Tissue Removed [ Time Frame: immediately post-treatment ] [ Designated as safety issue: No ]
  mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.
  
  

• Treatment Time Per Patient [ Time Frame: at time of treatment ] [ Designated as safety issue: No ]
  mean morcellation(division into and removal of small pieces, as of tissue) time per patient
  
  
• Fluid Volume Per Procedure [ Time Frame: at time of treatment ] [ Designated as safety issue: No ]
  mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.
  
  
• Fluid Deficit Per Procedure [ Time Frame: at time of treatment ] [ Designated as safety issue: Yes ]
  mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.
  
  
• Resected Tissue Weight Per Patient [ Time Frame: at time of treatment ] [ Designated as safety issue: No ]
  mean weight of resected tissue per patient
  
  
• Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score [ Time Frame: 2-3 months post treatment ] [ Designated as safety issue: No ]
  a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").
  
  
• Adverse Events [ Time Frame: 2-3 months post-treatment ] [ Designated as safety issue: Yes ]
  Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study
  
  

A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").