Post Market Evaluation of Acessa With TAG

A

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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