Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

Completed

• Conditions: Abnormal Uterine Bleeding; Infertility
• Interventions: Device: Interlace Medical 1st Generation Hysteroscopic Morcellator

• Registration Number: NCT01026805
• Lead Sponsor: Hologic, Inc.

Brief Summary

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

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").

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-04-30
• Results First Submitted: 2009-04-30
• Study First Submitted QC: 2009-11-03
• Results First Submitted QC: 2009-11-03
• Study First Posted: 2009-12-04
• Results First Posted: 2009-12-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-20
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hysteroscopic Morcellator	Interlace Medical 1st Generation Hysteroscopic Morcellator	11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.

Primary Outcome Measures

Name	Time	Method
Percentage of Tissue Removed	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 Outcome Measures

Name	Time	Method
Treatment Time Per Patient	at time of treatment	mean morcellation(division into and removal of small pieces, as of tissue) time per patient
Fluid Volume Per Procedure	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	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	at time of treatment	mean weight of resected tissue per patient
Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score	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	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