Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
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|ClinicalTrials.gov Identifier: NCT01026805|
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 4, 2009
Last Update Posted : November 22, 2012
|Condition or disease||Intervention/treatment|
|Abnormal Uterine Bleeding Infertility||Device: Interlace Medical 1st Generation Hysteroscopic Morcellator|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator|
|Study Start Date :||February 2009|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.
Device: Interlace Medical 1st Generation Hysteroscopic Morcellator
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 [ Time Frame: immediately post-treatment ]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 ]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 ]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 ]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 ]mean weight of resected tissue per patient
- Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score [ Time Frame: 2-3 months post treatment ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026805
|Principal Investigator:||Charles Miller, M.D.||Edward Hospital|