This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.
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").
Study Type
OBSERVATIONAL
Enrollment
11
The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.
Percentage of Tissue Removed
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.
Time frame: immediately post-treatment
Treatment Time Per Patient
mean morcellation(division into and removal of small pieces, as of tissue) time per patient
Time frame: at time of treatment
Fluid Volume Per Procedure
mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.
Time frame: at time of treatment
Fluid Deficit Per Procedure
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.
Time frame: at time of treatment
Resected Tissue Weight Per Patient
mean weight of resected tissue per patient
Time frame: at time of treatment
Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score
a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").
Time frame: 2-3 months post treatment
Adverse Events
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
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Time frame: 2-3 months post-treatment