Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026805
• Other study ID #: TMP 200901
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: November 20, 2012
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: November 2012
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Infertility
• Uterine Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	immediately post-treatment	No
Secondary	Treatment Time Per Patient	mean morcellation(division into and removal of small pieces, as of tissue) time per patient	at time of treatment	No
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.	at time of treatment	No
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.	at time of treatment	Yes
Secondary	Resected Tissue Weight Per Patient	mean weight of resected tissue per patient	at time of treatment	No
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").	2-3 months post treatment	No
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	2-3 months post-treatment	Yes