Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT01026805
First received: April 30, 2009
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Abnormal Uterine Bleeding
Infertility
Device: Interlace Medical 1st Generation Hysteroscopic Morcellator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 11
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hysteroscopic Morcellator
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.
Other Names:
  • MyoSure Tissure Removal System
  • MyoSure Tissure Removal Device

Detailed Description:

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").

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator to resect intrauterine pathology (polyps and submucous myomas).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026805

Sponsors and Collaborators
Hologic, Inc.
Investigators
Principal Investigator: Charles Miller, M.D. Edward Hospital
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01026805     History of Changes
Other Study ID Numbers: TMP 200901
Study First Received: April 30, 2009
Results First Received: April 30, 2009
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hologic, Inc.:
morcellator
hysteroscope
myomectomy
polypectomy
uterine fibroids

Additional relevant MeSH terms:
Hemorrhage
Infertility
Uterine Hemorrhage
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Uterine Diseases

ClinicalTrials.gov processed this record on April 17, 2014