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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.
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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hysteroscopic Morcellator | 11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interlace Medical 1st Generation Hysteroscopic Morcellator | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator to resect intrauterine pathology (polyps and submucous myomas).
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| Name | Affiliation | Role |
|---|---|---|
| Charles Miller, M.D. | Edward Hospital | Principal Investigator |
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An unselected series of eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator at four hospital or ambulatory surgical center sites were assessed for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hysteroscopic Morcellator Treatment Group | Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hysteroscopic Morcellator Treatment Group | Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Treatment Time Per Patient | mean morcellation(division into and removal of small pieces, as of tissue) time per patient | Posted | Mean | Full Range | minutes | at time of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hysteroscopic Morcellator Treatment Group | Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device. |
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Small number of cases; retrospective study design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Vozella, V.P. Clinical & Regulatory Affairs | Interlace Medical, Inc. | 508-875-1343 | 112 | john@interlacemedical.com |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D007246 | Infertility |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
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| 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 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| size of fibroid or polyp | measure size of pathology pre-treament via ultrasound or hysteroscopic exam | Mean | Full Range | mm |
|
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| Secondary | 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. | Posted | Mean | Full Range | mL | at time of treatment |
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|
|
| Secondary | 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. | Posted | Mean | Full Range | mL | at time of treatment |
|
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| Secondary | Resected Tissue Weight Per Patient | mean weight of resected tissue per patient | Posted | Mean | Full Range | g | at time of treatment |
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| Secondary | 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"). | All treating physicians completed a survey questionnaire. | Posted | Mean | Full Range | scores on a scale | 2-3 months post treatment |
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| Secondary | 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 | Posted | Number | events | 2-3 months post-treatment |
|
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| Primary | 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. | Posted | Mean | Full Range | Percentage of tissue removed | immediately post-treatment |
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| 0 |
| 11 |
| 0 |
| 11 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |