Trial Outcomes & Findings for Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator (NCT NCT01026805)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

11 participants

Primary outcome timeframe

immediately post-treatment

Results posted on

2012-11-22

Participant Flow

An unselected series of eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator at four hospital or ambulatory surgical center sites were assessed for this study.

Participant milestones

Participant milestones
Measure	Hysteroscopic Morcellator Treatment Group Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	40.5 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
size of fibroid or polyp	16.3 mm n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Percentage of Tissue Removed	97.5 Percentage of tissue removed Interval 50.0 to 100.0

SECONDARY outcome

Timeframe: at time of treatment

mean morcellation(division into and removal of small pieces, as of tissue) time per patient

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Treatment Time Per Patient	4.3 minutes Interval 0.2 to 22.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Fluid Volume Per Procedure	5179.0 mL Interval 600.0 to 24000.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Fluid Deficit Per Procedure	567.8 mL Interval 30.0 to 1900.0

SECONDARY outcome

Timeframe: at time of treatment

mean weight of resected tissue per patient

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Resected Tissue Weight Per Patient	10.8 g Interval 0.5 to 45.3

SECONDARY outcome

Timeframe: 2-3 months post treatment

Population: All treating physicians completed a survey questionnaire.

a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=4 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score	9.5 scores on a scale Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Hysteroscopic Morcellator Treatment Group n=11 Participants Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
Adverse Events	0 events

Adverse Events

Hysteroscopic Morcellator Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Vozella, V.P. Clinical & Regulatory Affairs

Interlace Medical, Inc.

Phone: 508-875-1343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60