Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator

Conditions
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Abnormal Uterine Bleeding, Infertility

Intervention / Treatment
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* Device: Interlace Medical 1st Generation Hysteroscopic Morcellator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female at least 18 years old treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hysteroscopic Morcellator<br>11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device. | Device: Interlace Medical 1st Generation Hysteroscopic Morcellator<br>* 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.<br>* Other names: MyoSure Tissure Removal Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | immediately post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Time Per Patient | mean morcellation(division into and removal of small pieces, as of tissue) time per patient | 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. | 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. | at time of treatment | 
| Resected Tissue Weight Per Patient | mean weight of resected tissue per patient | 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). | 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 | 2-3 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids