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Completed

NCT Number: NCT01026805

Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

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.

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Key information

Conditions

Abnormal Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Infertility Leiomyoma Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: MyoSure Tissure Removal System, MyoSure Tissure Removal Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Resected Tissue Weight Per Patient

    Time frame: at time of treatment

    mean weight of resected tissue per patient

  5. 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").

  6. 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

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2009
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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