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Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

NCT ID: NCT01026805

Last Updated: 2012-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

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").

Conditions

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Abnormal Uterine Bleeding Infertility

Keywords

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morcellator hysteroscope myomectomy polypectomy uterine fibroids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hysteroscopic Morcellator

11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.

Interlace Medical 1st Generation Hysteroscopic Morcellator

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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MyoSure Tissure Removal System MyoSure Tissure Removal Device

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Edward Hospital

Other Identifiers

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TMP 200901

Identifier Type: -

Identifier Source: org_study_id