Post Market Evaluation of Acessa With TAG

Acessa Health

Status: Terminated

Conditions: Uterine Fibroids

Treatments: Device: Acessa Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842789

CP-00-0021

Details and patient eligibility

About

The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).

Full description

The intent of the TAG system is to assist the gynecologist in getting the tip of the Acessa Handpiece to the fibroid by creating an animated image overlay of the movements and placement.

The study will be conducted in two parts:

Part 1: User Preference Testing - users will be presented with various statements pertaining to the features of the system and asked to indicate their degree of agreement.

Part 2: Time to target - will be measure by fibroid.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Women who:

• Are planning to undergo the Acessa procedure
• Are willing and able to comply with all procedures
• Are capable of providing informed consent

Exclusion Criteria: Women who:

• In the medical judgement of the investigator should not participate in this study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Acessa Procedure w/o TAG

Other group

Description:

Acessa Procedure without the use of Targeting Animation Guidance

Treatment:

Device: Acessa Procedure

Acessa Procedure with TAG

Other group

Description:

Acessa Procedure with Targeting Animation Guidance

Treatment:

Device: Acessa Procedure